MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-04-02 for ASCENSION PIP PIP-200 PIP-200-20D manufactured by Ascension Orthopedics, Inc..
[15501616]
Surgeon removed proximal and distal components due to a fracture of the proximal component. It is not known whether the fracture occurred intra-operatively or post-operatively. Implants were sent to hosp pathology dept.
Patient Sequence No: 1, Text Type: D, B5
[15657418]
Several attempts were made to retrieve implants from hospital pathology dept, but devices were not returned to ascension orthopedics. Therefore, evaluation was not possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2008-00005 |
| MDR Report Key | 1023718 |
| Report Source | 05 |
| Date Received | 2008-04-02 |
| Date of Report | 2008-03-07 |
| Date of Event | 2008-02-05 |
| Device Manufacturer Date | 2007-12-26 |
| Date Added to Maude | 2010-03-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LYNN FERGUSON |
| Manufacturer Street | 8700 CAMERON RD., STE. 100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal | 78754 |
| Manufacturer Phone | 5128365001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCENSION PIP |
| Generic Name | TOTAL FINGER JOINT IMPLANT |
| Product Code | KWF |
| Date Received | 2008-04-02 |
| Model Number | PIP-200 |
| Catalog Number | PIP-200-20D |
| Lot Number | 07-1716 |
| ID Number | NA |
| Device Expiration Date | 2011-11-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Address | 8700 CAMERON RD., STE. 100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-02 |