MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0/1.0 6 HOLE LONG; PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Catalog Number	01-9207
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced mandibular instability due to fracture of the plates that fixed during a right sagittal osteotomy.Therefore, the patient underwent a revision procedure.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in colombia.The 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
It was further reported that only two plates were removed during the revision procedure as only two plates were found to be fractured.This device was not removed and did not have any failures.Therefore, this report needs to be made not reportable.
Event or Problem Description
It was further reported that only two plates were removed during the revision procedure as only two plates were found to be fractured.This device was not removed and did not have any failures.Therefore, this report needs to be made not reportable.

• Brand Name: 2.0/1.0 6 HOLE LONG
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
• 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: 25068879
• Report Number: 0001032347-2026-00104
• Device Sequence Number: 10407494
• Product Code: GWO
• UDI-Device Identifier: 00841036017064
• UDI-Public: (01)00841036017064(10)892550(13)140101(30)10
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: Lay User/Patient
• Device Catalogue Number: 01-9207
• Device Lot Number: 67626346
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2014
• 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: Female