OMNISPAN MENISCAL REPAIR 12DEG Adverse Event — Malfunction (MDR 1221934-2020-01242)
OMNISPAN MENISCAL REPAIR 12DEG Adverse Event — Malfunction (MDR 1221934-2020-01242) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OMNISPAN MENISCAL REPAIR 12DEG; Generic name: SOFT-TISSUE ANCHOR, BIOABSORBABLE; Manufacturer: DEPUY MITEK LLC US.
| Device | OMNISPAN MENISCAL REPAIR 12DEG |
|---|---|
| Generic name | SOFT-TISSUE ANCHOR, BIOABSORBABLE |
| Manufacturer | DEPUY MITEK LLC US |
| Report number | 1221934-2020-01242 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==> ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING THE SURGERY OF RIGHT KNEE MENISCUS SUTURE, AFTER 1ST FIRING WITH 228141, TWO PLATE WERE DEPLOYED AT THE SAME |
| Source | openFDA MAUDE (device adverse events) |
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