MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-20 for MCP SZ. 10 DISTAL WW MCP-100-10D-WW manufactured by Ascension Orthopedics.
[38641866]
It was reported the device was initially implanted (b)(6) 2013. At a later time the patient complained of increasing pain, discomfort and stiffness. It was reported a 2nd surgery was necessary to remove the implant. The revision surgery occurred on (b)(6) 2015. The distal part of the implant was removed and replaced by another one with a bigger size.
Patient Sequence No: 1, Text Type: D, B5
[41635876]
Integra has completed their internal investigation on 22mar2016. The investigation included: methods: review of device history records. Review of complaint history. Results: no product/manufacturing issues were identified that would have caused or contributed to the event. A review of the complaint files found two complaints for an mcp implant being replaced for pain or stiffness. According to sales data, there have been (b)(4) procedures for the mcp system. This equates to an occurrence rate of (b)(4). Conclusion: a definitive root cause cannot be established, as the implant was not returned. Possible root causes may include incorrect sizing during the initial surgery, or injury to or other physiological impairment of the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2016-00014 |
| MDR Report Key | 5449883 |
| Date Received | 2016-02-20 |
| Date of Report | 2016-01-25 |
| Date of Event | 2015-12-03 |
| Date Mfgr Received | 2016-03-22 |
| Device Manufacturer Date | 2009-10-29 |
| Date Added to Maude | 2016-02-20 |
| 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 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. 10 DISTAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2016-02-20 |
| Catalog Number | MCP-100-10D-WW |
| Lot Number | 09-2106 |
| 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 | 2016-02-20 |