MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-10-09 for ASCENSION PIP PIP-200-20D manufactured by Ascension Orthopedics, Inc..
[1122079]
Pt complained that her pip orthopedic implant was protruding from her finger and had to be removed a week after surgery. She was searching for a surgeon to "reinsert the half that was taken out. "
Patient Sequence No: 1, Text Type: D, B5
[8418969]
The initial contact from the pt was done via email with a request for a surgeon in her area. She wanted to have a component that was removed inserted back into her finger. Her implant is made up of two separate components and it is unclear what was removed (either one or both). A second mdr is being submitted (1651501-2009-022) to cover both components. A review of mfg records did not indicate any deficiencies that may have led to this event. If additional info is obtained, we will re-evaluate this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2009-00023 |
| MDR Report Key | 1512209 |
| Report Source | 04 |
| Date Received | 2009-10-09 |
| Date of Report | 2009-10-09 |
| Date of Event | 2008-10-30 |
| Date Mfgr Received | 2009-09-09 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2009-10-23 |
| 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 | 2009-10-09 |
| Model Number | NA |
| Catalog Number | PIP-200-20D |
| Lot Number | 08-1469 |
| ID Number | NA |
| Device Expiration Date | 2012-07-01 |
| 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. AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-10-09 |