MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-04-08 for MCP SZ. 30 PROXIMAL WW MCP-100-30P-WW manufactured by Ascension Orthopedics.
[141329449]
The device involved in the reported incident is not available for evaluation. As such, a failure analysis could not be conducted. A review of the lot records was conducted, and did not find any indication of problems that could have caused or contributed to the complaint. As the implant was not returned for investigation, a possible root cause could not be found.
Patient Sequence No: 1, Text Type: N, H10
[141329450]
A customer reported that on (b)(6) 2019, a pyrocarbon mcp (id (b)(6)) had snapped during a metacarpophalangeal joint (mcpj) arthroplasty. The snapped implant was noticed on x-rays two (2) days post-surgery and has been left implanted as it did not appear to be affecting the patient. The patient had no issues and so no plans to revise at this stage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00010 |
| MDR Report Key | 8493334 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-17 |
| Date of Event | 2019-03-05 |
| Date Mfgr Received | 2019-03-17 |
| Date Added to Maude | 2019-04-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCP SZ. 30 PROXIMAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2019-04-08 |
| Catalog Number | MCP-100-30P-WW |
| Lot Number | 17349ST |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |