MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-22 for MCP IMPLANT TRAY MCP IMPLANTS manufactured by Ascension Orthopedics.
[22641015]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
[22641016]
It was reported the device broke during a procedure. During implantation, the stem of the proximal implant broke. The geometry of the bone is quite special. The implantation was prepared with appropriate instruments following the surgical technique. It was reported there was no patient injury. The event led to increased surgery time but the delay is unknown.
Patient Sequence No: 1, Text Type: D, B5
[28592664]
Integra completed its internal investigation 8/26/2015. The investigation included: method: complaint trend. Results: complaint records with identical or similar alleged hazardous situation/failure mode received as specified in the rmp were reviewed to determine if the complaint represents an isolated incident or if it is part of an adverse trend. The complaint rate was calculated based on the number of devices affected by the hazardous situation or failure mode, over the number of surgeries or units sold during the period of time of the review. A total of (b)(4) complaints were received. According to sales data, the complaint occurrence rate for the reported failure is (b)(4). Conclusion the lot number of the device was not communicated by the complainant, and the device was not returned to integra for analysis. Multiple attempts were made by the integra personnel to make contact with the distributor for lot information and return status, but no inquiries were ever answered. Therefore, it is not possible to determine a root cause due to the limited information provided for this case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2015-00019 |
| MDR Report Key | 4938377 |
| Date Received | 2015-07-22 |
| Date of Report | 2015-06-25 |
| Date of Event | 2015-01-15 |
| Date Mfgr Received | 2015-08-26 |
| Date Added to Maude | 2015-07-24 |
| 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 MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE 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 IMPLANT TRAY |
| Product Code | NEG |
| Date Received | 2015-07-22 |
| Catalog Number | MCP IMPLANTS |
| 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 | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-22 |