MAUDE Adverse Event Report: BIOMET MICROFIXATION THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW, 1.5 X 4 MM; FASTENER, SCREW, CRANIOPLASTY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (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:0001032347-2019-00141, 0001032347-2019-00150, & 0001032347-2019-00151.
Event or Problem Description
It was reported a revision will occur due to the patient evolving with an infectious disease.This patient is planned to be implanted with a pekk implant.Attempts have been made and no further information has been provided.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of evidence that supports the revision was performed.As these parts were removed in revision, the complaint is considered confirmed.No product was returned and no inspection could be performed.No x-rays, scans, pictures, or physician's reports were provided.Dhr was reviewed and no discrepancies were found.There was nothing to indicate that the infection is related to these implants or there was an alleged malfunction of these implants.There are no indications of manufacturing defects.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.Ultiple mdr reports were filed for this event, please see associated reports:0001032347-2019-00141-1, 0001032347-2019-00150-1, & 0001032347-2019-00151-1.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW, 1.5 X 4 MM
• Common Device Name: FASTENER, SCREW, CRANIOPLASTY
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8396576
• Report Number: 0001032347-2019-00152
• Device Sequence Number: 3219302
• Product Code: HBW
• UDI-Device Identifier: 00841036134808
• UDI-Public: 00841036134808
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K121624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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 Model Number: N/A
• Device Catalogue Number: 91-6704
• Device Lot Number: 092700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 07/01/2019
• 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