MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA TRIAL, 9MM; MBA SUBTALAR IMPLANT SYSTEM

Catalog Number 050209

Device Problems Off-Label Use (1494); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/24/2017

Event Type  malfunction  

Event Description

Trial mba implant was implanted instead of the final implant.Revision surgery was planned for (b)(6) 2017.Patient age and gender unknown; reported as a young patient.The issue was observed when the customer returned the set to integra after the procedure.The sales manager contacted the surgeon to double check with him if trial part was implanted and it was confirmed by the surgeon.

Manufacturer Narrative

Integra has completed their internal investigation on december 27, 2017.Results: dhr review; no lot number was provided for the trial; however, all records available for this part number were reviewed to ensure that lots had been inspected visually and passed for the ¿trial¿ laser etch.This was confirmed.Complaints history; a query in the short description field for trial and implanted showed no previous results of a trial being implanted.From 2012 to present (october 2017), there have been 8,934 mba surgeries performed.This represents (b)(4) overall failure rate.Conclusion: based on the information to date, the root cause appears to be user error as the surgeon implanted the trial.The surgical technique for the mba system states that the trial should be removed following determination of the appropriate sized trial implant, and the failure analysis shows that there is identification of a trial part as a trial.

• Brand Name: TRIAL, 9MM
• Type of Device: MBA SUBTALAR IMPLANT SYSTEM
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7064320
• MDR Text Key: 93809289
• Report Number: 3004608878-2017-00320
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1