MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW, DIA. 6.5MM X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	701M6550
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was conducted to address pedicle screw haloing at all levels of an l4-s1 construct.The diameter of all screws was upsized and the construct was extended from l3-pelvis.There was no reported patient impact beyond the revision surgery.This is report four of six for this event.
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.D10: 6x closure tops (07.02010.001), 2x ø5.5 precut curved rods, ti alloy 65mm (07.02015.010), 1x medium cross connector (94672) 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.Reference reports 3012447612-2026-00040 through 3012447612-2026-00045.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.The lot number was not reported and the device was not returned, therefore a dhr review is unable to be performed.The device was not returned and no photos were provided, so an evaluation is unable to be performed.The complaint is unrefuted for vital polyaxial screw for the failure of loosening.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 a revision surgery was conducted to address pedicle screw haloing at all levels of an l4-s1 construct.The diameter of all screws was upsized and the construct was extended from l3-pelvis.There was no reported patient impact beyond the revision surgery.This is report four of six for this event.

• Brand Name: POLYAXIAL SCREW, DIA. 6.5MM X 50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 24241039
• Report Number: 3012447612-2026-00043
• Device Sequence Number: 21379202
• Product Code: NKB
• UDI-Device Identifier: 03662663200035
• UDI-Public: (01)03662663200035
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171907
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: 701M6550
• Was Device Available for Evaluation?: No
• 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: 02/02/2026
• Supplement Report FDA Received Date: 06/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic