MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-10-30 for ASCENSION PIP PIP-200-20D-WW manufactured by Ascension Orthopedics, Inc..
[1304958]
Revision surgery was conducted because the right ring finger pip had dislocated. It was discovered during surgery that the proximal pip joint had broke.
Patient Sequence No: 1, Text Type: D, B5
[8360395]
A mfg record review was conducted. No issues were identified that would have caused or contributed to this event. The device was not returned for eval. Based on the claim that the device was fractured, it is reasonable that a fracture on the proximal component would cause a dislocation. This report is for the distal component. It was removed when the fractured proximal component was removed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2009-00024 |
| MDR Report Key | 1519869 |
| Report Source | 06 |
| Date Received | 2009-10-30 |
| Date of Report | 2009-10-30 |
| Date of Event | 2009-03-13 |
| Date Mfgr Received | 2009-04-06 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2009-11-05 |
| 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 | KEN THOMA |
| Manufacturer Street | 8700 CAMERON RD |
| 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 | 2009-10-30 |
| Model Number | PIP-200-20D-WW |
| Lot Number | 08-1056 |
| Device Expiration Date | 2012-05-31 |
| 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. Required No Informationntervention | 2009-10-30 |