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

Catalog Number	48955106
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision of a dorsal stabilization surgery, the surgeon hammered a cage in which got stuck and could not be hammered any further.Consistent use of the impactor led to the breakage.Both fragments could be safely removed.Another cage was used to complete the procedure.No adverse consequences to the patient were reported.
Event or Problem Description
It was reported that during a revision of a dorsal stabilization surgery, the surgeon hammered a cage in which got stuck and could not be hammered any further.Consistent use of the impactor led to the breakage.Both fragments could be safely removed.Another cage was used to complete the procedure.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, risk assessment.Result: the reported event was confirmed via correspondence and visual inspection of the returned cage.Manufacturing history review was performed on the reported lot# no manufacturing related issue was found.Per surgical technique, ¿carefully insert the cage gently and progressively into the disc space using a mallet when necessary.If difficulty is encountered while inserting the implant, it most likely represents contralateral disc material which may be blocking passage of the implant, inadequate distraction, an undersized annulotomy or oversized implant.¿ conclusion: as per capa, the potential factors that might be leading to the intra-op fractures includes thickness of wall adjacent to lateral window, size of lateral window, user overestimating strength of implant and applying excessive force (torsional, cantilever), not following surgical technique guide; using oversized implant or wrong type/size of inserter, not distracting when inserting or repositioning, use of ¿twist & distract¿ method.The root causes of the reported cage fracture via impaction overloading is due to deviation of 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: 7870650
• Report Number: 3004024955-2018-00044
• Device Sequence Number: 16825888
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: 07613327118087
• Combination Product (Y/N): N
• 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): 11/13/2018

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: No Information
• Device Catalogue Number: 48955106
• Device Lot Number: D7N7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1