MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-03-31 for ASCENSION PIP PIP-200 PIP-200-10D manufactured by Ascension Orthopedics, Inc..
[21994263]
The implant components satisfied all applicable manufacturing specifications. The implants did not display any evidence of damage due to function over the approximately one year duration implant duration. There was no evidence to suggest that the distal implant surface chips had existed for a significant period of time. See scanned pages.
Patient Sequence No: 1, Text Type: N, H10
[22172914]
Device was removed from patient as it was "eroding through the skin". The surgeon noted that the erosion was not caused by operative tech or implants, but possible further degenerative rheumatoid arthritis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2008-00008 |
| MDR Report Key | 1023644 |
| Report Source | 08 |
| Date Received | 2008-03-31 |
| Date of Report | 2008-03-31 |
| Date of Event | 2008-01-23 |
| Date Mfgr Received | 2008-02-20 |
| Device Manufacturer Date | 2006-08-04 |
| Date Added to Maude | 2008-08-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LYNN FERGUSON |
| Manufacturer Street | 8700 CAMERON ROAD 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 | 2008-03-31 |
| Returned To Mfg | 2008-03-13 |
| Model Number | PIP-200 |
| Catalog Number | PIP-200-10D |
| Lot Number | 06-1322 |
| ID Number | NA |
| Device Expiration Date | 2010-06-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1021415 |
| Manufacturer | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Address | 8700 CAMERON ROAD STE. 100 AUSTIN TX 78754 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-31 |