MAUDE Adverse Event Report: BIOMET MICROFIXATION 1479157 PM-TMJ & MODEL; CUSTOM MADE DEVICE

Model Number N/A

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device has not been returned; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source¿ (b)(6).

Event Description

It was reported that during the procedure for a left side temporomandibular joint implant that no correct occlusion could be established with splint.After consultation with the planning surgeon, it was decided to stop the operation and analyze the error.It was further reported that the old fossa components were re-implanted suture-secured and, as before, small sterile hoses were inserted as placeholders and fixed with some palacos.

Event Description

It was reported that during the procedure for a left side temporomandibular joint implant that no correct occlusion could be established with splint.After consultation with the planning surgeon, it was decided to stop the operation and analyze the error.It was further reported that the old fossa components were re-implanted suture-secured and, as before, small sterile hoses were inserted as placeholders and fixed with some palacos.It is now further reported that a new design has been created for this case.The revision date is still to be determined.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.No vsp orthognathics planning session took place to set the occlusion, because this case would only need an occlusal adjustment.Patient stone models were not provided for this case, however, patient intraoral scans were provided, which were used in the design of the splint.The scan data was not faulty for the misalignment of the implants.No errors were found in the integration, use, or printing of the digital and physical models.The 3ds investigation concluded there was no reasonable substantiation to the suggestion that the planned occlusion was misaligned.The plan and design were both approved by zimmer biomet and the surgeon.Final inspection and fit check passed per the relevant work instructions.3ds investigation suggested the most likely root cause is miscommunication between the two surgeons, as only one was involved with approving the device design.Surgeon approval of the final design includes the approval of the final occlusion.It was reported that the physicians disagreed on the placement procedure.However, without medical records a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 1479157 PM-TMJ & MODEL
• Type of Device: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12188691
• MDR Text Key: 262412364
• Report Number: 0001032347-2021-00375
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

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 Model Number: N/A
• Device Catalogue Number: TMJPM-3320
• Device Lot Number: 047530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female