BIOHORIZONS HEX ABUTMENTS Adverse Event — Malfunction (MDR 1060818-2020-03202)
BIOHORIZONS HEX ABUTMENTS Adverse Event — Malfunction (MDR 1060818-2020-03202) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BIOHORIZONS HEX ABUTMENTS; Generic name: HEX ABUTMENTS; Manufacturer: BIOHORIZONS IMPLANT SYSTEMS.
| Device | BIOHORIZONS HEX ABUTMENTS |
|---|---|
| Generic name | HEX ABUTMENTS |
| Manufacturer | BIOHORIZONS IMPLANT SYSTEMS |
| Report number | 1060818-2020-03202 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | THE PRODUCT THE THREE (3) MALFUNCTION EVENTS WERE NOT RETURNED FOR INVESTIGATION. THEREFORE, NO CONCLUSION MAY BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON CONFORMANCES. THEREFORE, THE CONCLUSION MAY BE DRAWN THAT PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. WITH THE PRODUCT BEIGN MANUFACTURED TO SPECIFICATION, THE STRIPPED SCREW WOULD OCCUR OUTSIDE OF THE MANUFACTURERS PU |
| Source | openFDA MAUDE (device adverse events) |
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