MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,07 report with the FDA on 2013-08-28 for NUGRIP SZ. 3020 THB-442-3020-WW manufactured by Ascension Orthopedics, Inc..
[15097908]
It was reported "the patient was enrolled in a clinical study. A right thumb trapeziometacarpal joint arthroplasty with a nugrip implant was performed on (b)(6) 2010. The patient experienced persistent pain (on an unknown date) following the surgery. A post-operative x-ray was performed which demonstrated a subsidence of the "cmc orthosphere" into the trapezium and actually a little site of fracture of the trapezium. The patient had a subjective clinical exam consistent with carpal tunnel. In addition she also had dysesthesia along the dorsum aspect of the thumb indicative of injury to the sensory branch of the radial nerve. A revision surgery and nugrip implant removal was performed on (b)(6) 2011. Post-operative diagnosis: failure of carpal metacarpal arthroplasty of the right thumb, carpal tunnel syndrome and fracture of the trapezium. "
Patient Sequence No: 1, Text Type: D, B5
[15282186]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2013-00027 |
| MDR Report Key | 3322597 |
| Report Source | 02,05,07 |
| Date Received | 2013-08-28 |
| Date of Report | 2013-08-28 |
| Date Mfgr Received | 2013-08-06 |
| Date Added to Maude | 2013-09-04 |
| 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 | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUGRIP SZ. 3020 |
| Generic Name | NUGRIP |
| Product Code | KYI |
| Date Received | 2013-08-28 |
| Catalog Number | THB-442-3020-WW |
| Operator | HEALTH PROFESSIONAL |
| 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 | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-28 |