MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MGT MOVEMENT PROX. PHAL. TOTAL SZ 20; MOVEMENT GREAT TOE

Lot Number 10-1204

Device Problem Peeled/Delaminated (1454)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

This is the second report of two reports concerning the same patient.(see mfg report number 1651501-2014-00021).This report concerns the movement great toes system (mgt) movement proximal phalanx.Total size 20 (product id mgt-890-20ppt).It was reported: 'surgery was an mgt total toe.Surgery went fine but the patient soon began to have pain.The surgeon went back in to replace the implant and found that the cobalt chrome had peeled off the head of the implant.' additional information was received from the distributor on (b)(6)-2014.The date of the initial implant surgery was (b)(6)-2013.The implant was implanted in the left foot of the patient.The patient had discomfort soon after the surgery which progressed until the implant was removed (and toe was later fused) on (b)(6)-2014.The patient condition to date was reported as 'improved'.The implant was reported given to the patient and is not available for evaluation.Additional information was requested by integra.

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: MGT MOVEMENT PROX. PHAL. TOTAL SZ 20
• Type of Device: MOVEMENT GREAT TOE
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; austin TX
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536-3832 ; 6099362341
• MDR Report Key: 3810009
• MDR Text Key: 4523722
• Report Number: 1651501-2014-00022
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 10-1204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2014
• Initial Date FDA Received: 05/01/2014
• 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: 68 YR