MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0X5MM HT X-DRIVE SCREW; FASTENER, PLATE, CRANIOPLASTY

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a jaw deformity underwent a combined ivro and ssro procedure.Later, an x-ray confirmed that a screw on the ivro side loosend from the plate, and infection was suspected.Infection was confirmed and treatment was started.Subsequently, patient was revised.The surgeon has determined that the dislodged screw may have had some effect on the development of the infection.
Additional Manufacturer Narrative
Zimmer biomet (b)(4).G2: foreign source: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional 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.This is a non-sterile product related infection and is not considered a zb issue as it is labeled as non-sterile and presumed to be sterilized and readied elsewhere; therefore, products are not identified as the source or contributing to the reported infection.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h3, h6, h10 and h11.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 2.0X5MM HT X-DRIVE SCREW
• Common Device Name: FASTENER, PLATE, CRANIOPLASTY
• 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20076324
• Report Number: 0001032347-2024-00286
• Device Sequence Number: 11529123
• Product Code: HBW
• UDI-Device Identifier: 00841036053376
• UDI-Public: (01)00841036053376(10)J7304286
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-2005
• Device Lot Number: J7304286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown