MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-10-07 for MCP SZ. 50 PROXIMAL WW MCP-100-50P-WW manufactured by Ascension Orthopedics.
[168608061]
The device has not been returned to date; however, images provided show that the device was removed in three pieces. If the device is returned to integra, the complaint will be updated accordingly. Review of the dhr for lot 152948t shows that no nonconformances were generated and all units in the lot met specifications at the time of final release. Based on the visual review of the explanted components (images), it is unclear how/when the fracture occurred; however, the fracture appearance is consistent with a rapid brittle, bending fracture. It is unclear if the breakage occurred during implant (during impaction) and went unnoticed or occurred post-implant due to patient action.
Patient Sequence No: 1, Text Type: N, H10
[168608062]
A distributor reported that on (b)(6) 2019, a patient underwent revision of a proximal pyrocarbon mcp implant (id mcp-100-50p-ww - mcp sz. 50 proximal ww) that was used as a hemi replacement in the right index finger. Revision surgery was indicated 6-8 months post initial surgery due to a fractured stem. The patient presented due to complaining of pain. No known incident was reported that to have caused the fracture, and the patient was reported to have followed the postoperative instructions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00041 |
| MDR Report Key | 9162567 |
| Report Source | USER FACILITY |
| Date Received | 2019-10-07 |
| Date of Report | 2019-09-10 |
| Date of Event | 2019-09-06 |
| Date Mfgr Received | 2019-09-10 |
| Date Added to Maude | 2019-10-07 |
| 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 | MRS. VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362319 |
| 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. 50 PROXIMAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2019-10-07 |
| Catalog Number | MCP-100-50P-WW |
| Lot Number | 152948T |
| 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 | 2019-10-07 |