MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-03-13 for MCP SZ. 20 DISTAL WW MCP-100-20D-WW manufactured by Ascension Orthopedics.
[102247219]
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
[102247222]
It was reported that the mcp was implanted on (b)(6) 2012 and on (b)(6) 2018, the patient had second surgery to remove the implant as it was broken. Another implant (same size) was implanted. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[131596898]
Integra has completed their internal investigation on march 13, 2018. Results: dhr review; no nonconformances that may have contributed to the event. Complaints history; a software search of the results containing broken mcp showed four complaints of post-operative mcp/smcp breakage/fracture from february 2016 to present. Conclusion: the part was not returned; however, a picture of the mcp in two pieces was provided, confirming that the event occurred. The root cause is unknown. Patient trauma or injury is a potential root cause.
Patient Sequence No: 1, Text Type: N, H10
[131597279]
Additional information received on march 21, 2018: when was the breakage observed? Did the patient have symptoms? If yes, please describe: answer: a patient (b)(6) years old, operated in (b)(6) 2012 (metacarpophalangeal implant of the 2? Toe). In (b)(6) 2013 his 2? Toe presented stiff, so he needed a new surgery by arthrolysis. The patient has had a favourable evolution with annual controls without any incident, any sign of osteolysis or any loosening of the implant. On (b)(6) 2017 the patient went to visit the doctor because he had an intense and sudden pain in the distal phalanx of his 2? Toe, without any previous traumatism, nor sudden movement. Radiography showed the broken implant. Were there any events which could lead to breakage (fall? )? : answer: no, there weren? T. What are the underlying medical conditions of patient? Answer: they are not detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2018-00020 |
| MDR Report Key | 7335014 |
| Report Source | FOREIGN |
| Date Received | 2018-03-13 |
| Date of Report | 2018-02-20 |
| Date Mfgr Received | 2018-04-23 |
| Date Added to Maude | 2018-03-13 |
| 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. 20 DISTAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2018-03-13 |
| Returned To Mfg | 2018-04-10 |
| Catalog Number | MCP-100-20D-WW |
| Lot Number | 11-2463 |
| 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 | 2018-03-13 |