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

Catalog Number XXX-MGT IMPLANT

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A patient reported misalignment of the mgt (movement great toe system) implant and pain and is seeking alternatives to correct the misalignment.The system was implanted on (b)(6) 2019 due to arthritis.During a follow up visit on (b)(6) 2019, an x-ray was taken showing the misalignment.The doctor attempted to physically force the joint into alignment, which was painful, but not successful.The patient is experiencing pain walking any distance and standing at any duration.The change in his gait is now causing problems with his ankle and knee.The patient confirms that there were no traumatic or contributing event.The physician attributed the dislocation to scar tissue on the extensor tendon which was keeping the toe from pointing down.The patient went through physical therapy for 60 days, which did not resolve the situation.In a follow up visit on (b)(6) 2020, the physician stated that he needed to do another procedure in his office by which he would use ¿a large needle¿ to break up the scar tissue.

Manufacturer Narrative

Complaint sample was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Between (b)(6) 2019 and (b)(6) 2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period (b)(6) 2019 through (b)(6) 2020.Integra lifesciences contacted (b)(6) , director of regulatory programs, office of product evaluation and quality and (b)(6) , assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

Event Description

N/a.

• 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
• MDR Report Key: 10280176
• MDR Text Key: 206772783
• Report Number: 1651501-2020-00005
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• PMA/PMN Number: K092047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR