MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-05 for MGT IMPLANT - UNSPECIFIED XXX-MGT IMPLANT manufactured by Ascension Orthopedics.
[61441719]
Integra completed its internal investigation 18nov2016. The investigation included: method: - review of complaint management database for similar complaints. Results: no information has been provided by complainant that identifies the device as other than a great toe device. No lot number or product id was given therefore the manufacturing record for the implant could not be determined. Complaint records for the same product (or similar products within the product family) for the alleged hazardous situation/failure mode received during the lifetime of the product, typically 5 years or within the stated timeframe, were reviewed. This is the second incident reported of a movement great toe loosening or backing out after implementation for the past two years. (b)(4). Conclusion: given the description of the event and the observations made during the documentary investigation and the lack of returned product or supportive information, the root cause cannot be determined. Per the product line risk documentation, potential root cause may be improper bone preparation, improper size selection, improper placement and alignment.
Patient Sequence No: 1, Text Type: N, H10
[61441720]
Additional information received indicates the product initially reported in mfg. Report 9615741-2015-00054 was incorrect. The product involved is an mgt implant. Nature of complaint: "loosening of implant / pain / metallosis. " action taken: "removal of implant and revision to first metatarsophalangeal fusion with iliac crest bone graft. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2016-00045 |
| MDR Report Key | 6145298 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-05 |
| Date of Report | 2015-10-13 |
| Date Mfgr Received | 2016-11-08 |
| Date Added to Maude | 2016-12-05 |
| 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 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 | MGT IMPLANT - UNSPECIFIED |
| Generic Name | MOVEMENT GREAT TOE SYSTEM |
| Product Code | LZJ |
| Date Received | 2016-12-05 |
| Catalog Number | XXX-MGT IMPLANT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-12-05 |