MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. PLATE 2 HOLE TI 10MM ASSY; LANX FUSION SYSTEM- SA

Catalog Number	8605-0210
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.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.
Event or Problem Description
It was reported that two timberline mpf plates detached from the cage in the disc space intra-operatively.The surgery was completed after a 30 minute delay without any patient harm using another plate.This is report one of two for this event.
Event or Problem Description
It was reported that two timberline mpf plates detached from the cage in the disc space intra-operatively.The surgery was completed after a 30 minute delay without any patient harm using another plate.This is report one of two for this event.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed no signs of damage.A functional inspection was performed with a timberline cage (8603-5012 lot mc43203), a cover plate (8606-0200 lot md41960).A driver (8734-6118 lot mc57565) was used to attach the plate and cover plate to the cage and found the plate was able to secure to the cage as expected.Root cause: a definitive root cause cannot be determined with the information provided.No device problem was found.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3012447612-2024-00236.

• Brand Name: PLATE 2 HOLE TI 10MM ASSY
• Common Device Name: LANX FUSION SYSTEM- SA
• 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: 20042473
• Report Number: 3012447612-2024-00235
• Device Sequence Number: 18135341
• Product Code: OVD
• UDI-Device Identifier: 00887868197581
• UDI-Public: (01)00887868197581(10)MD78125
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K123767
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: 8605-0210
• Device Lot Number: MD78125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 08/22/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2021
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic