MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB2.0MM4HOLEEXTSTRPLATE; PLATE, FIXATION, BONE

Catalog Number	915-2111
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Loss of fracture reduction (4901)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in china.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.
Event or Problem Description
It was reported that approximately 12 days post-implantation, the patient experienced bone flap collapse necessitating a second craniotomy.During the reoperation, intraoperative findings included severe deformation of the left upper connector plate and complete fracture of the left lower connector plate.The screws remained intact, and only the four-hole connector plate was damaged.The patient had no history of trauma, and the prosthesis was not reshaped using a water bath during the initial surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: d6a, d6b, g3, h2, h3, h6, h10 and h11.Complaint can be confirmed through the returned product analysis.A visual inspection was conducted on the returned plates and screws.The plates and screws arrived without the packaging.The items show signs of attempted use including marking and scratching on the plate and screw surfaces as well as residue from the surgery.One of the two plates has fractured.The additional parts returned show no signs of fracture or damage.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: LACTOSORB2.0MM4HOLEEXTSTRPLATE
• Common Device Name: PLATE, FIXATION, BONE
• 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: 24484441
• Report Number: 0001032347-2026-00056
• Device Sequence Number: 10684937
• Product Code: HRS
• UDI-Device Identifier: 00841036054564
• UDI-Public: (01)00841036054564(17)271003(10)473200
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971870
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: 915-2111
• Device Lot Number: 473200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown