MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-01-13 for MGT MOVEMENT PROX. PHAL. TOTAL SZ. 40 MGT-890-40PPT manufactured by Ascension Orthopedics.
[35757069]
It was reported the implant backed out for some unknown reason and the patient required a revision. It was reported the event is surgeon error. "there was nothing wrong with the implant. It just backed out and the joint dislocated. "
Patient Sequence No: 1, Text Type: D, B5
[40407271]
Additional information received 8mar16: the product was used. It won't be returned. There was nothing wrong with it. Integra completed its internal investigation 25feb16. The investigation included: method: review of device history records. Review of complaint management database for similar complaints. Results: no product/manufacturing issues were identified that would have caused or contributed to the event. A review of the complaint files found one complaint for an mgt proximal phalanx backing out. (b)(4). Conclusion: as the implant was not returned, a definitive root cause cannot be established. Possible root causes may include not following the surgical technique, or other surgeon errors.
Patient Sequence No: 1, Text Type: N, H10
[40407272]
Corrected event type to adverse event. Information provided indicates there was no product problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2016-00001 |
| MDR Report Key | 5362982 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-01-13 |
| Date of Report | 2015-12-22 |
| Date of Event | 2015-12-15 |
| Date Mfgr Received | 2016-02-25 |
| Date Added to Maude | 2016-01-13 |
| 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 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 MOVEMENT PROX. PHAL. TOTAL SZ. 40 |
| Generic Name | MOVEMENT GREAT TOE |
| Product Code | KWD |
| Date Received | 2016-01-13 |
| Catalog Number | MGT-890-40PPT |
| Lot Number | 15-2669 |
| 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 | 2016-01-13 |