MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-20 for MCP SZ. 30 DISTAL WW MCP-100-30D-WW manufactured by Ascension Orthopedics.
[117581677]
The device will not be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[117581678]
A customer reported that a mcp-100-30d-ww mcp sz. 30 distal ww stem broke while implanted and a revision surgery was required to replace the product. Additional information was received indicating that the patient is doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2018-00053 |
| MDR Report Key | 7796945 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-20 |
| Date of Report | 2018-08-01 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-08-20 |
| 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 DISTAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2018-08-20 |
| Catalog Number | MCP-100-30D-WW |
| Lot Number | 152548T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-08-20 |