MAUDE Adverse Event Report: PRECISION SPINE, INC SHURFIT INTERBODY DEVICE; INTERBODY CAGE

Model Number	ALIF0832-11P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
It was reported that a 5 level procedure was performed on (b)(6) 2025, utilizing the shurfit alif interbody cage system.Following insertion of size 11 trial, while attempting to insert an alif cage peek 8 degree 11mm x 32mm (alif0832-11p) in l2, the cage cracked across the cage alongside the threaded inserter assembly hole.The broken cage was removed and while a second cage of the same size was being inserted, it also cracked in the same way.This cage was removed and a third cage of the same size was successfully implanted without issue.There was no patient injury, but a delay to the procedure of twenty-four minutes was reported.
Event or Problem Description
It was reported that a 5 level procedure was performed on december 2, 2025, utilizing the shurfit alif interbody cage system.Following insertion of size 11 trial, while attempting to insert an alif cage peek 8 degree 11mm x 32mm (alif0832-11p) in l2, the cage cracked across the cage alongside the threaded inserter assembly hole.The broken cage was removed and while a second cage of the same size was being inserted, it also cracked in the same way.This cage was removed and a third cage of the same size was successfully implanted without issue.There was no patient injury, but a delay to the procedure of twenty-four minutes was reported.
Additional Manufacturer Narrative
H3 device evaluation - both returned cages exhibit fractures at the central threaded connection point as well as damage to the central thread location.One of the cages also exhibits thread damage to the oblique threaded location.On both cages the lateral threaded connection is undamaged.The inserter used when both cages were damaged was not returned and therefore cannot be ruled out as a possible mode of failure.It is also unclear what visible damage was incurred during insertion versus removal of the implants.Root cause cannot be determined.Review of device history records found twenty-five (b)(4) pieces of lot 36427ps released for distribution on 7/19/2021 with no deviation or anomalies.Two-year complaint history review (12.3.2023-12.3.2025) found this to be the only report of this nature for any of the part numbers in the shurfit alif peek cage family.No corrective action is recommended.

• Brand Name: SHURFIT INTERBODY DEVICE
• Common Device Name: INTERBODY CAGE
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 23927946
• Report Number: 3005739886-2025-00023
• Device Sequence Number: 8824891
• Product Code: KWQ
• UDI-Device Identifier: 00840019912075
• UDI-Public: (01)00840019912075(11)210609(10)36427PS
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K092193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: ALIF0832-11P
• Device Catalogue Number: ALIF0832-11P
• Device Lot Number: 36427PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown