MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI DS88-200210 LEFT TEMPORAL PARIETAL IMPLANT; CUSTOM MADE DEVICE

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it remains implanted; 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 the custom cranial plate was too large and had to be altered intraoperatively prior to implantation.The custom plate was successfully implanted although the surgeon does not believe the result is perfect due to the implant being too thick, especially in the frontal area.No adverse events have been reported as a result of the malfunction.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.No product was returned, as it was reported the implant was modified to complete the procedure.No x-rays, scans, pictures, or physician's reported were provided.The design vendor and manufacturer of this device was notified of the fit issue and performed an investigation and provided their results.The design vendor found that the implant design provided meets all requirements and has been found satisfactory.The dhr for this product was reviewed, no non-conformances were found.There are no indications of manufacturing defects.For patient matched htr-pmi implants (pmxxxxxx) in the previous year (from the notification date) regarding fit issues with the implant, (b)(4).The root cause of this complaint was determined to be outside the scope of the design/manufacturing process.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: HTR-PMI DS88-200210 LEFT TEMPORAL PARIETAL IMPLANT
• Type of Device: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9920598
• MDR Text Key: 191272941
• Report Number: 0001032347-2020-00198
• Device Sequence Number: 1
• Product Code: KKY
• UDI-Device Identifier: 00841036282981
• UDI-Public: 00841036282981
• Combination Product (y/n): N
• PMA/PMN Number: K924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: N/A
• Device Catalogue Number: PM622996
• Device Lot Number: 971110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1