MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for BONE PLATE, MP, 16 HOLE 55-08216 manufactured by Stryker Leibinger Freiburg.
[184812427]
The device is not available for evaluation as it was discarded by the facility at their location. If additional information is received it will be reported in a supplemental report. The product was discarded by the facility at their location.
Patient Sequence No: 1, Text Type: N, H10
[184812428]
It was reported by a surgeon that a patient required a revision surgery due to experiencing pain and having pus secretions approximately 4-5 weeks after initial implantation with an implant. The original procedure was reported as completed successfully without a delay, but during the revision surgery it was found that the screws had loosened, calcification formed near the plate, and a patient swab tested as mrsa positive. The plate was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2020-00016 |
| MDR Report Key | 9876841 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GREGORY GOHL |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Country | DE |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER LEIBINGER FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Country | DE |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE PLATE, MP, 16 HOLE |
| Generic Name | IMPLANT |
| Product Code | JEY |
| Date Received | 2020-03-25 |
| Model Number | 55-08216 |
| Catalog Number | 55-08216 |
| Lot Number | 00000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER FREIBURG |
| Manufacturer Address | BOETZINGERSTR. 41 FREIBURG D-79111 DE D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |