MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-03-31 for PCR CEMENT RESTRICTOR 4202026 manufactured by Sofamor Danek Deggendorf Gmbh.
[402121]
Pt was implanted with peek cement restrictor filled with infuse bone graft and cd horizon sextant posterior fixation. It is reported that "the procedure failed. " approx 14 months post op, a revision surgery was performed by a different surgeon to remove a rod and remove part of the peek cement restrictor. The surgeon noted that the device was "malpositioned and was impinging on nerves. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2005-00085 |
| MDR Report Key | 587329 |
| Report Source | 04 |
| Date Received | 2005-03-31 |
| Date of Report | 2005-03-04 |
| Date of Event | 2004-04-30 |
| Date Mfgr Received | 2005-03-04 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2005-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RICHARD TREHARNE, PH.D. |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Street | WERTSTRASSE 17 |
| Manufacturer City | DEGGENDORF 94469 DE |
| Manufacturer Country | * |
| Manufacturer Postal Code | 94469 DE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PCR CEMENT RESTRICTOR |
| Generic Name | CEMENT RESTRICTOR |
| Product Code | JDK |
| Date Received | 2005-03-31 |
| Model Number | NA |
| Catalog Number | 4202026 |
| Lot Number | HC79 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 577176 |
| Manufacturer | SOFAMOR DANEK DEGGENDORF GMBH |
| Manufacturer Address | WERTSTRASSE 17 DEGGENDORF * 94469 |
| Baseline Brand Name | PCR CEMENT RESTRICTOR |
| Baseline Generic Name | CEMENT RESTRICTOR |
| Baseline Model No | NA |
| Baseline Catalog No | 4202026 |
| Baseline ID | NA |
| Baseline Device Family | MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K010528 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-03-31 |