MAUDE Adverse Event Report: STRYKER SPINE-US 11MM X 0DEG X 9MM X 23MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48950110
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	12/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon sent picture of patient who originally had a t11-pelvis fusion on (b)(6) 2018.Image shows both rods had popped out of the pelvic screws and the cage at l4-l5 had backed out.Required revision of fusion (screws added at s1; and rods re-seated and revised in pelvic bolts), extraction of cage, and closure of dural tear at l4/l5.
Additional Manufacturer Narrative
Method: labelling review, risk assessment.Result: the customer reported event was confirmed via x-ray by doctor and correspondence.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: based on the surgical technique statement, "the compression or distraction maneuvers should be performed once all of the blockers are inserted but not final tightened".Because the supplemental system was reported to have migrated too, the root cause of the reported cage migration is likely due to the migrated/looseness of the supplemental fixation system.
Event or Problem Description
Surgeon sent picture of patient who originally had a t11-pelvis fusion on (b)(6) 2018.Image shows both rods had popped out of the pelvic screws and the cage at l4-l5 had backed out.Required revision of fusion (screws added at s1; and rods re-seated and revised in pelvic bolts), extraction of cage, and closure of dural tear at l4/l5.

• Brand Name: 11MM X 0DEG X 9MM X 23MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8243721
• Report Number: 3004024955-2019-00002
• Device Sequence Number: 1911786
• Product Code: MAX
• UDI-Device Identifier: 07613327117370
• UDI-Public: 07613327117370
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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: No Information
• Device Catalogue Number: 48950110
• Device Lot Number: D44D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2018
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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
• Patient Age: 45 YR