MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI VASQUE TORRES LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT; MATERIAL, POLYETRAFLOUROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTI

Model Number N/A

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

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Event date: (b)(6) 2019; implant date: (b)(6)2019; report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the implant on the front did not fit well and they had to press.The implant was delivered in (b)(6) 2017 but due to patient problems it could not be placed until 2019.The doctor had to reduce the implant a little before placing, because after almost two years it is logical that the implant would not fit.When trying to place it, the surgeon forced too much and made the wound.The revision due to infection is captured on mfr #0001032347-2019-00158 through 0001032347-2019-00160.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Reported event was confirmed by review of post-operative ct scans.Upon review of the ct scans, it can be seen that the implant does not fit the patient's defect area well.No product was returned and no test or inspections could be performed.This implant was eventually removed in a revision due to infection.The distributor suggested it may have been caused from a wound created when the physician tried to place the implant.The distributor provided that the implant was placed approximately 18 months post-manufacturing.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to changes in the patient's anatomy from the time of the initial scan was taken for the design of the implant to when the implant was placed.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.

Event Description

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

• Brand Name: HTR-PMI VASQUE TORRES LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT
• Type of Device: MATERIAL, POLYETRAFLOUROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTI
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8403636
• MDR Text Key: 138228690
• Report Number: 0001032347-2019-00161
• Device Sequence Number: 1
• Product Code: KKY
• UDI-Device Identifier: 00841036235734
• UDI-Public: 00841036235734
• Combination Product (y/n): N
• PMA/PMN Number: K924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: N/A
• Device Catalogue Number: PM619689
• Device Lot Number: 772860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention