MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW (DIA.5.0 MM X 30 MM L); APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	07.01708.012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a virage open connector could not be inserted between c7 and t1 intraoperatively because of interference with the inferior facet joints and lamina located beneath the rod.The surgeon removed the screw at t1 to allow for more room for the open connector.However, the head of the screw fractured during removal.There was a five-minute delay to remove the screw and the procedure was completed without any patient impacts.
Additional Manufacturer Narrative
Corrections in d4: lot & udi numbers, d9, and h3.Additional information in h4.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 a virage open connector could not be inserted between c7 and t1 intraoperatively because of interference with the inferior facet joints and lamina located beneath the rod.The surgeon removed the screw at t1 to allow for more room for the open connector.However, the head of the screw fractured during removal.There was a five minute delay to remove the screw and the procedure was completed without any patient impacts.
Event or Problem Description
It was reported that a virage open connector could not be inserted between c7 and t1 intraoperatively because of interference with the inferior facet joints and lamina located beneath the rod.The surgeon removed the screw at t1 to allow for more room for the open connector.However, the head of the screw fractured during removal.There was a five minute delay to remove the screw and the procedure was completed without any patient impacts.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in 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 the lower housing of the screw has fractured resulting in the screw disassembling.The weld penetration depth was inspected on both sides of each of the two pieces of the lower housing.The penetration depth measured 0.019" on all four sides.They meet the required depth of 0.010" - 0.020" as required by the drawing 07.01708.000 rev e, which this screw was manufactured to.Therefore, there were no problems identified with the weld.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for virage polyaxial screw for the failure of fracture.The failure could be attributed to off-axis and/or excessive forces being applied beyond intended use.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.

• Brand Name: POLYAXIAL SCREW (DIA.5.0 MM X 30 MM L)
• 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: 23879883
• Report Number: 3012447612-2025-00403
• Device Sequence Number: 21238311
• Product Code: KWP
• UDI-Device Identifier: 03662663112123
• UDI-Public: (01)03662663112123(10)AAY
• 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
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 04/26/2026

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: 07.01708.012
• Device Lot Number: AAY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/30/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.5/5.5MM SIDE OPEN ROD CONNECTOR (07.01725.001).
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic