MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-09-25 for MCP SZ. 30 DISTAL WW MCP-100-30D-WW manufactured by Ascension Orthopedics.
[26965866]
It was reported the device fractured. It was reported that the patient is a mechanic, he works with his hands. He had returned to work and was on light duty. The patient reported hitting/jamming his finger. "the detailed description by the patient did not sound like anything that would have caused the implant to fracture. " following the incident, the patient had pain and swelling, leading to the office visit and x-rays where the fracture was discovered. Currently the patient is removed from working and is waiting for further treatment recommendation from the care team. A revision procedure is expected. Operative report from initial surgery (b)(6) 2015: preoperative diagnosis: severe osteoarthritis of the left mcp joint. Procedure: left hand third mcp joint: resectional arthroplasty with ascension orthopedics pyrocarbon implant (size #30). Application of volar splint. Summary of report: uneventful implantation procedure.
Patient Sequence No: 1, Text Type: D, B5
[34372716]
Additional information received 18nov2015: the revision surgery has been completed as of yesterday (b)(6) 2015. I have the explanted implants on hand that have been washed and sterilized. Integra has completed their internal investigation on 1dec2015. The investigation activities included: methods: evaluation of actual device. Review of device history records. Review of complaint history. Results: the review of manufacturing records showed no evidence of nonconformance that could have caused or contributed to the reported defect. (b)(4). Conclusion: the investigation determined that the fracture is most likely the result of a traumatic injury suffered by the patient.
Patient Sequence No: 1, Text Type: N, H10
[34372717]
.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2015-00035 |
| MDR Report Key | 5105584 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-09-25 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2015-11-18 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-09-25 |
| 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 |
| Reporter Occupation | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| 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 | 2015-09-25 |
| Returned To Mfg | 2015-11-20 |
| Catalog Number | MCP-100-30D-WW |
| Lot Number | 142698T |
| 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 | 1. Required No Informationntervention | 2015-09-25 |