MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. PLATE BUTTRESS 1 HOLE TI 14MM ASSY; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Catalog Number	8605-0114
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported that they had a timberline mpf plate buttress 1 hole ti 14mm assy where the screw ¿fell apart.' event timing was not provided; however, it was assumed to have occurred intra-operatively.
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.The lot number was not provided, so the dhr was unable to be reviewed.The device was not returned and no photos were provided, so an evaluation is unable to be performed.The complaint is unrefuted for timberline plate for the failure of disassembly.This device is used for treatment.The investigation findings do not lead to a clear conclusion about the cause of the reported event.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
A distributor reported that they had a timberline mpf plate buttress 1 hole ti 14mm assy where the screw ¿fell apart.' event timing was not provided, however it was assumed to have occurred intra-operatively.

• Brand Name: PLATE BUTTRESS 1 HOLE TI 14MM ASSY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 23609649
• Report Number: 3012447612-2025-00367
• Device Sequence Number: 21326659
• Product Code: OVD
• UDI-Device Identifier: 03662663250658
• UDI-Public: (01)03662663250658
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131547
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8605-0114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic