MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-03-24 for ASCENSION PIP PIP-200 PIP-200-20D manufactured by Ascension Orthopedics, Inc..
[811057]
Surgeon examined x-ray of patient post-op and thought implant was broken, but was mistaken. Revision surgery was performed to reposition the same implant.
Patient Sequence No: 1, Text Type: D, B5
[8047307]
Revision surgery was not the result of implant failure, but surgical technique error. Device was not removed.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1651501-2008-00009 |
MDR Report Key | 1023755 |
Report Source | 08 |
Date Received | 2008-03-24 |
Date of Report | 2008-03-24 |
Date of Event | 2008-02-11 |
Date Mfgr Received | 2008-02-11 |
Device Manufacturer Date | 2007-04-05 |
Date Added to Maude | 2009-05-05 |
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 | 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 | 2008-03-24 |
Model Number | PIP-200 |
Catalog Number | PIP-200-20D |
Lot Number | 07/0407 |
ID Number | NA |
Device Expiration Date | 2011-02-01 |
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 | 2008-03-24 |