MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-05 for MCP SZ. 05 PROXIMAL WW MCP-110-05P-WW manufactured by Ascension Orthopedics.
[64020085]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[64020086]
It was reported that the proximal mcp implant was implanted upside down. The surgeon is an experienced user but seemed to have difficulty during this case. During the implantation, the implant was positioned and removed several times. X-rays provided show the implant mal-positioned. A revision surgery has been discussed and scheduled with the patient. Currently the device remains implanted and the patient is in a postoperative splint.
Patient Sequence No: 1, Text Type: D, B5
[65836355]
Integra has completed their internal investigation on january 23, 2017. The investigation included: methods: review of device history records, review of complaints history. Results: attempts for additional information and product return have been unsuccessful to date; therefore, no failure analysis has been performed. Dhr review; review of manufacturing records showed no evidence of a nonconformance that may have caused or contributed to the reported event. Complaints history; a search of the results of the field containing? Mcp? January 2012 to present showed no previous complaints of an mcp implant being implanted upside down. During this period of time, there have been (b)(4) mcp surgeries performed. This represents a (b)(4) overall failure rate. Conclusion: as the device has not been returned and attempts for additional information have been unsuccessful to date, the root cause of the report cannot not be confirmed at this time; however, based on the information provided, the event appears to be due to surgeon difficulties encountered during the implant process. Should additional information be provided, the investigation will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2016-00050 |
| MDR Report Key | 6227006 |
| Date Received | 2017-01-05 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-12-09 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2017-01-05 |
| 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 SONIA IRIZARRY |
| 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. 05 PROXIMAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2017-01-05 |
| Catalog Number | MCP-110-05P-WW |
| Lot Number | 154068T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-01-05 |