MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MGT IMPLANT - UNSPECIFIED; MOVEMENT GREAT TOE SYSTEM

Catalog Number XXX-MGT IMPLANT

Device Problems Mechanical Problem (1384); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.".

• Brand Name: MGT IMPLANT - UNSPECIFIED
• Type of Device: MOVEMENT GREAT TOE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6145298
• MDR Text Key: 61441719
• Report Number: 1651501-2016-00045
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• PMA/PMN Number: K102549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-MGT IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention