MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW, DIA. 8.5MM X 50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	709M8550
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
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 one year post-operatively, a patient presented with worsening pain and pseudoarthrosis at l2-3 and l5-s1 with loose screws bilaterally at s1 and at left l2.A revision surgery was performed where the screws were removed.The l2 screw was replaced with a larger diameter screw.The screws could not be replaced at s1; instead they were moved to iliac bilaterally.This is report one of three for this event.
Additional Manufacturer Narrative
H6: additional method code: 4110.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned.X-ray images were provided but were post-operative images, therefore the device loosening could not be confirmed.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Dhr review: the lot number was not reported and the device was not returned, therefore a dhr review is unable to be performed.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 reports 3012447612-2025-00054 through 3012447612-2025-00056.
Event or Problem Description
It was reported that one year post-operatively, a patient presented with worsening pain and pseudoarthrosis at l2-3 and l5-s1 with loose screws bilaterally at s1 and at left l2.A revision surgery was performed where the screws were removed.The l2 screw was replaced with a larger diameter screw.The screws could not be replaced at s1; instead they were moved to iliac bilaterally.This is report one of three for this event.

• Brand Name: POLYAXIAL SCREW, DIA. 8.5MM 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: 21410542
• Report Number: 3012447612-2025-00054
• Device Sequence Number: 21226524
• Product Code: NKB
• UDI-Device Identifier: 00880304868366
• UDI-Public: (01)00880304868366
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171907
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 06/24/2025

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: 709M8550
• 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: 02/19/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic