MAUDE Adverse Event Report: STRYKER SPINE-US POSTERIOR LUMBAR CAGE 10MM X 23MM X6DEG - 9MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48950106
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location is unknown.
Event or Problem Description
A company representative reported that patient was revised to address a tritanium pl cage which backed out approximately six weeks post-operatively.The patient also reported experiencing pain.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was discarded by the hospital.Device history records were reviewed for the reported lot number, no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.Review of provided x-ray confirms that the cage is posterior to the disc space where it should be located.It was unable to be determined where the cage was initially placed as no immediate post-op x-rays were provided.Follow up communication with the field confirms that the device was implanted on (b)(6) 2022 and the patient was revised on (b)(6) 2022.The patient did not experience any post-op trauma, the post-op activity level is unknown and it was further reported that the patient has soft bone.Stryker es2 screw and rod system was used for fixation, it is unknown if fusion occurred or not, although complete fusion is not expected at 2 months post-op the most likely cause of the reported event was unable to be determined with the information provided.Without an immediate post-op x-ray the initial location of the implant and degree of migration cannot be determined.Additionally, it is unknown what the patient¿s post-op activity level was.The patients soft bone quality may have contributed to the event but cannot be determined conclusively.H3 other text : hospital discarded device.
Event or Problem Description
A company representative reported that patient was revised to address a tritanium pl cage which backed out approximately six weeks post-operatively.The patient also reported experiencing pain.

• Brand Name: POSTERIOR LUMBAR CAGE 10MM X 23MM X6DEG - 9MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14418927
• Report Number: 0009617544-2022-00057
• Device Sequence Number: 14840922
• Product Code: MAX
• UDI-Device Identifier: 07613327117417
• UDI-Public: 07613327117417
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 08/08/2022

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 Model Number: 48950106
• Device Catalogue Number: 48950106
• Device Lot Number: E1ML
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2017
• 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: 77 YR
• Patient Sex: Male