MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,08 report with the FDA on 2014-08-14 for PIP SZ 30 PROXIMAL PIP-200-3OP-WW manufactured by Ascension Orthopedics.
[4803877]
It was reported pip sz 30 proximal broke during surgery. Add'l info was requested numerous times by integra.
Patient Sequence No: 1, Text Type: D, B5
[12260040]
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 | 1651501-2014-00041 |
| MDR Report Key | 4023899 |
| Report Source | 01,06,07,08 |
| Date Received | 2014-08-14 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-07-10 |
| Date Mfgr Received | 2014-07-24 |
| Date Added to Maude | 2014-08-29 |
| 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 | 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 30 PROXIMAL |
| Generic Name | PIP |
| Product Code | NEG |
| Date Received | 2014-08-14 |
| Catalog Number | PIP-200-3OP-WW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2014-08-14 |