MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-04 for MIDDLE PHALANGEAL BROACH, SIZE 2 SR PIP 171331 manufactured by Stryker Gmbh.
[156740096]
Upon completion of investigation, additional information will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[156740097]
Upon incoming inspection, items were visibly worn. No associated procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2019-01244 |
| MDR Report Key | 8962914 |
| Date Received | 2019-09-04 |
| Date of Report | 2019-11-08 |
| Date of Event | 2019-08-08 |
| Date Mfgr Received | 2019-10-14 |
| Device Manufacturer Date | 2009-11-06 |
| Date Added to Maude | 2019-09-04 |
| 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. ANNA JUSINSKI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER GMBH |
| Manufacturer Street | BOHNACKERWEG 1 POSTFACH |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDDLE PHALANGEAL BROACH, SIZE 2 SR PIP |
| Generic Name | SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS |
| Product Code | MPK |
| Date Received | 2019-09-04 |
| Returned To Mfg | 2019-09-13 |
| Catalog Number | 171331 |
| Lot Number | 1027301 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER GMBH |
| Manufacturer Address | BOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-04 |