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
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00159 and 0001032347-2019-00160.
Event or Problem Description
It was reported the patient developed a wound where the implant did not fit and that wound is infected.The implant was replaced and now everything is fine.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Reported event was confirmed by review of evidence that the revision was performed.No product was returned and no test or inspections could be performed.The reason for the revision was due to infection.The distributor provided two post-operative ct scans from the implantation surgery.Upon review of the ct scans, no conclusions could be reached in regards to the infection.The distributor suggested it may have been caused from a wound created when the physician tried to place the implant.However, this could not be confirmed based on the materials provided.Dhr and sterile certificates were reviewed and no discrepancies or nor anomalies were found.Root cause was unable to 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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00159-1 and 0001032347-2019-00160-1.
Event or Problem Description
This follow-up is being submitted to relay additional information.

• Brand Name: HTR-PMI VASQUE TORRES LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT
• Common Device Name: MATERIAL, POLYETRAFLOUROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTI
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8403691
• Report Number: 0001032347-2019-00158
• Device Sequence Number: 10867671
• Product Code: KKY
• UDI-Device Identifier: 00841036235734
• UDI-Public: 00841036235734
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K924935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention