MAUDE Adverse Event Report: STRYKER SPINE-US 8MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48950086
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital discarded.
Event or Problem Description
It was reported that a right side tritanium pl cage at l4/5 migrated approximately 1 month post-operatively.Revision surgery was performed where the implant was removed and replaced.
Event or Problem Description
It was reported that a right side tritanium pl cage at l4/5 migrated approximately 1 month post-operatively.Revision surgery was performed where the implant was removed and replaced.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.Per additional correspondence, patient's post op activity level and bone quality is unknown.No external trauma was reported.It is unknown if fusion was achieved.No complications during the initial procedure were reported.Patient did not have tight disc space.It is unknown if any supplemental fixation system installed.Surgeon was reported to be familiar with the tri pl insertion technique.Implant was not inserted/impacted at an angle during initial surgery.Normal impaction force was applied to the inserter.Implant was not repositioned after insertion.From the tritanium pl surgical technique: early loosening may result from inadequate initial fixation, latent infection, premature loading of the device or trauma.Late loosening may result from trauma, infection, biological complications or mechanical problems, with the subsequent possibility of bone erosion, or pain.Due to lack of information and device not returned, an exact cause of the reported event could not be determined.Potential causes include: inadequate initial fixation, latent infection, premature loading of the device or trauma, improper cage size, patient bone quality, patient activity level, and inadequate preparation of the disc space can contribute to the event.

• Brand Name: 8MM X 6DEG X 9MM X 23MM
• 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: 12094189
• Report Number: 3004024955-2021-00018
• Device Sequence Number: 14305597
• Product Code: MAX
• UDI-Device Identifier: 07613327117349
• UDI-Public: 07613327117349
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 48950086
• Device Catalogue Number: 48950086
• Device Lot Number: ND04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention