TM ARDISA INTERBODY SYSTEM SOLID Adverse Event — Injury (MDR 3005751028-2020-00053)
TM ARDISA INTERBODY SYSTEM SOLID Adverse Event — Injury (MDR 3005751028-2020-00053) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TM ARDISA INTERBODY SYSTEM SOLID; Generic name: PROSTHESIS, SPINE; Manufacturer: ZIMMER TMT.
| Device | TM ARDISA INTERBODY SYSTEM SOLID |
|---|---|
| Generic name | PROSTHESIS, SPINE |
| Manufacturer | ZIMMER TMT |
| Report number | 3005751028-2020-00053 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR, FOREIGN, HEALTH PR |
| Narrative | (B)(4) VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED BIOLOGICAL DEBRIS IN THE TRABECULAR METAL OF THE IMPLANT, CONFIRMING THE REVISION. PROVIDED RADIOGRAPHS IDENTIFIED A DISLODGMENT OF THE INTERVERTEBRAL CAGE AT L5-S1 INTO THE SPINAL CANAL. BONE QUALITY WAS NORMAL. NO DEFINITE ABNORMALITY SEEN WITHIN THE PATIENT'S ANATOMY OR PRODUCT POSITION THAT COULD EXPLAIN THE DISLOCATION. REVIEW OF TH |
| Source | openFDA MAUDE (device adverse events) |
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