MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-25 for ASCENSION ORTHOPEDICS, UNKNOWN DEVICE manufactured by Ascension Orthopedics, Inc..
[1174307]
Surgeon reported that he performed a cmc arthroplasty on a pt and it repeatedly dislocated medially due to laxity of the collateral ligaments. The type of cmc implant used is unk. The surgeon attempted to correct the issue by tightening the collateral ligaments and up sizing the implant, but this was unsuccessful. He also reported that another surgeon treated the pt subsequently. The second surgeon used the abductor pollicus longus (apl) for a lrti arthroplasty. It is unk whether the implant was removed.
Patient Sequence No: 1, Text Type: D, B5
[8369026]
Limited info has been received for this event. Ascension is awaiting more details about the original surgery and the device(s) involved. A supplemental report will be filed if further info is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2009-00020 |
| MDR Report Key | 1489978 |
| Report Source | 05 |
| Date Received | 2009-09-25 |
| Date of Report | 2009-09-25 |
| Date Mfgr Received | 2009-08-27 |
| Date Added to Maude | 2011-03-22 |
| 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 | LYNN FERGUSON |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCENSION ORTHOPEDICS, UNKNOWN DEVICE |
| Generic Name | UNK |
| Product Code | KWF |
| Date Received | 2009-09-25 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| 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. Required No Informationntervention | 2009-09-25 |