MAUDE Adverse Event Report: STRYKER SPINE-US OIC PEEK SPACER 11 X 20 X 4 DEG - 9; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	6760114
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We were provided two possible lot numbers for the device and will update the record if we receive more information.The lot number could be 257099 or 257217.
Event or Problem Description
A customer reported that a patient was revised approximately three weeks post-operatively to address a migrated xia serrato polyaxial screw.The patient reported experiencing low back pain.
Additional Manufacturer Narrative
Corrected data: b5, d1, d4, g4.Updated information and imaging provided from the field indicates that the affected device is an oic peek spacer.This device is not approved for use in the us.Therefore, this event is no longer reportable to the fda.
Event or Problem Description
A customer reported that a patient was revised approximately three weeks post-operatively to address a migrated oic peek spacer.The patient reported experiencing low back pain.

• Brand Name: OIC PEEK SPACER 11 X 20 X 4 DEG - 9
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 23499000
• Report Number: 0009617544-2025-00099
• Device Sequence Number: 18357447
• Product Code: NKB
• UDI-Device Identifier: 07613327351958
• UDI-Public: (01)07613327351958(11)250813(10)257099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: Health Professional
• Device Catalogue Number: 6760114
• Device Lot Number: 74242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• 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
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian