MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-09 for MCP GENERIC manufactured by Ascension Orthopedics.
[126688975]
Dhr - no product information was provided; therefore, no dhr review can be performed. Failure analysis - the device has not been returned for investigation. If the product is returned, the investigation will be updated accordingly. The root cause is unknown as the product has not been returned; however, patient activity is a possible contributing factor.
Patient Sequence No: 1, Text Type: N, H10
[126688976]
It was reported that a patient underwent pyrocarbon mcp revision on (b)(6) 2018. The distal component stem broke off in the proximal phalanx canal. The proximal component was reported to be completely intact and unaffected. It is estimated the implants had been in the patient for 3-5 years. The implants were revised to a silicone implant on (b)(6) 2018. The patient is recreational gun enthusiast and shoots his weapons competitively on a regular basis. There was considerable graphite absorbed in the surrounding soft tissues which remained after being thoroughly irrigated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2018-00060 |
| MDR Report Key | 8055742 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-09 |
| Date of Report | 2018-09-24 |
| Date Mfgr Received | 2018-12-03 |
| Date Added to Maude | 2018-11-09 |
| 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 GENERIC |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2018-11-09 |
| Returned To Mfg | 2018-11-30 |
| Catalog Number | MCP GENERIC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-09 |