MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-15 for PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 3 SRPIP3 manufactured by Stryker Gmbh.
[161694624]
Device was not returned. If additional information becomes available, it will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[161694625]
The customer reported that a stryker sbi loan kit arrived at the hospital missing an implant. The patient had already been anaesthetized before the surgeon realized. Once he realized, the surgeon attempted to obtain an implant from (another site) in order to run the case. This was not possible. The patient was kept under anesthetic for 1. 5 hours and then the case was abandoned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008031020-2019-01052 |
| MDR Report Key | 8898405 |
| Date Received | 2019-08-15 |
| Date of Report | 2019-09-13 |
| Date of Event | 2019-07-23 |
| Date Mfgr Received | 2019-08-19 |
| Date Added to Maude | 2019-08-15 |
| 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. KEVIN SMITH |
| 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 | 0 |
| Brand Name | PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 3 |
| Generic Name | SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS |
| Product Code | MPK |
| Date Received | 2019-08-15 |
| Catalog Number | SRPIP3 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-08-15 |