MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-04-07 for PIP SZ 40 PROXIMAL PIP-200-40P-WW manufactured by Ascension Orthopedics.
[15361308]
It was reported the third proximal pip implant of the left hard of the pt "snapped after his hand got 'wrangled, in the leash of his (b)(6) golden retriever. On (b)(6), 2014, the pt consulted with his surgeon. An x-ray was performed which revealed that the proximal tip of the pip was broken. The pt was scheduled for revision surgery on (b)(6), 2014. Add'l info was requested by integra.
Patient Sequence No: 1, Text Type: D, B5
[15546707]
To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2014-00020 |
| MDR Report Key | 3763398 |
| Report Source | 04 |
| Date Received | 2014-04-07 |
| Date of Report | 2014-03-14 |
| Date of Event | 2013-12-12 |
| Date Mfgr Received | 2014-03-14 |
| Date Added to Maude | 2014-04-23 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIP SZ 40 PROXIMAL |
| Generic Name | PIP |
| Product Code | KWF |
| Date Received | 2014-04-07 |
| Catalog Number | PIP-200-40P-WW |
| Lot Number | 05-0677 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-07 |