MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MGT MOVEMENT PROX. PHAL. TOTAL SZ. 40; MOVEMENT GREAT TOE

Catalog Number MGT-890-40PPT

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 12/15/2015

Event Type  Injury  

Event Description

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.".

Manufacturer Narrative

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.

Event Description

Corrected event type to adverse event.Information provided indicates there was no product problem.

• Brand Name: MGT MOVEMENT PROX. PHAL. TOTAL SZ. 40
• Type of Device: MOVEMENT GREAT TOE
• 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: 5362982
• MDR Text Key: 35757069
• Report Number: 1651501-2016-00001
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K060560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MGT-890-40PPT
• Device Lot Number: 15-2669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• 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
• Patient Age: 54 YR