MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. TRANSVERSE CONNECTOR, ROD TO ROD (35 MM W); APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	07.01721.003
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the transverse connector was inserted into the body, the left side engaged properly with the rod, but the right side did not engage correctly.As a result, the connector was removed and not used.Intraoperatively, it was confirmed from a distance that the connector had sufficient engagement range, and there was no apparent contact with the bone or other structures.Both clamps were loosened and handed to the surgeon.Since the right side would not engage, the surgeon loosened it slightly further.Although attempts were made to push in the right side, applying excessive force could have caused cervical spine injury.After several attempts, the procedure was completed as planned, but without implanting the transverse connector.There was no patient impact.
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.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.An inspection of the part shows revealed debris in the threads of the insert.A functional inspection was performed by attempting to thread the nut on the insert which revealed force needed to be applied to turn the nut.Further functional inspection with a virage spine model revealed both inserts were able to attach to the rods.This event likely cannot be attributed to manufacturing or design related issues.The complaint is unrefuted for virage tranverse connector for the failure of misalignment.A definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.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.
Event or Problem Description
It was reported that when the transverse connector was inserted into the body, the left side engaged properly with the rod, but the right side did not engage correctly.As a result, the connector was removed and not used.Intraoperatively, it was confirmed from a distance that the connector had sufficient engagement range, and there was no apparent contact with the bone or other structures.Both clamps were loosened and handed to the surgeon.Since the right side would not engage, the surgeon loosened it slightly further.Although attempts were made to push in the right side, applying excessive force could have caused cervical spine injury.After several attempts, the procedure was completed as planned, but without implanting the transverse connector.There was no patient impact.

• Brand Name: TRANSVERSE CONNECTOR, ROD TO ROD (35 MM W)
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 23842575
• Report Number: 3012447612-2025-00385
• Device Sequence Number: 21321579
• Product Code: KWP
• UDI-Device Identifier: 03662663112673
• UDI-Public: (01)03662663112673(10)T11264
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133556
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 07.01721.003
• Device Lot Number: T11264
• 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: 12/18/2025
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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: Unknown
• Patient Ethnicity: Non Hispanic