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 2013-08-27 for NUGRIP SZ. 10S NUG-443-10S manufactured by Ascension Orthopedics, Inc..
[3953558]
It was reported the patient was enrolled in a clinical study. A right thumb arthroplasty with a nugrip prosthesis implant was performed (b)(6) 2010. "the patient had no reported problem for 1. 5 years and then experienced "some pain". It was noted there was loosening in the prosthesis and malalignment. She was then in a motorcycle accident and this became painful. It was obvious that the implant was loose. There was sliding to the implant, as well into the trapezium, as compared to previous films. A revision and implant removal surgery was performed on (b)(6) 2012. "
Patient Sequence No: 1, Text Type: D, B5
[11135528]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2013-00025 |
| MDR Report Key | 3322400 |
| Report Source | 02,05,07 |
| Date Received | 2013-08-27 |
| Date of Report | 2013-08-27 |
| 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 DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Street | 8700 CAMERON RD., STE. 100 |
| Manufacturer City | AUSTIN TX 78754383 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 3832 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUGRIP SZ. 10S |
| Generic Name | NUGRIP |
| Product Code | KYI |
| Date Received | 2013-08-27 |
| Catalog Number | NUG-443-10S |
| 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 | 8700 CAMERON RD., STE. 100 AUSTIN TX 78754383 US 78754 3832 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-27 |