MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48955106
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when 'the scrub tech opened the sterile tritanium pl cage it was broken/bent in the package' intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
D4 has been updated from 'd858' to 'dde9' following device receipt.
Event or Problem Description
It was reported that when 'the scrub tech opened the sterile tritanium pl cage it was broken/bent in the package' intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Event or Problem Description
It was reported that when 'the scrub tech opened the sterile tritanium pl cage it was broken/bent in the package' intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Upon visual inspection, the cage was found to be fractured.The cage was twisted, which is indicative of a rotation of the cage.Particles appearing to be bone and tissue were found in the pores of the cage, meaning this cage was attempted to be implanted.The packaging was not returned with the cage.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or complaints were identified.It was reported that when the scrub tech opened the sterile tritanium pl cage it was broken/bent in the package.The cage was returned without any of the packaging.However, particles appearing to be bone and tissue were found in the pores of the cage, indicating that this cage was attempted to be implanted.The tritanium pl surgical technique includes an explicit precaution: " do not twist, cantilever or rotate to achieve final position.This may result in damage to the implant".Based on the deformation seen and the bone particles found in the cage, it appears that this cage was attempted to be implanted and was twisted in the disc space, which is warned against in the surgical technique.

• Brand Name: 10MM X 6DEG X 11MM X 28MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10984610
• Report Number: 3004024955-2020-00046
• Device Sequence Number: 14208047
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: 07613327118087
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2021

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 Model Number: 48955106
• Device Catalogue Number: 48955106
• Device Lot Number: DDE9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/10/2020; 02/26/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 12/30/2020; 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1