MAUDE Adverse Event Report: STRYKER SPINE-US 14X28X12DEG-11; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48953142
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the cage cracked and remained implanted.No adverse consequences to the patient has been reported.
Additional Manufacturer Narrative
Method: product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the reported event of cannot be confirmed due to the lack of x-ray image and no product return.The device remained implanted in patient.The crack was reported to be recognized via x-ray at the end of the surgery.Manufacturing history review was performed on the reported lot# no manufacturing related issue was found.A capa was opened to investigate the cause(s) and contributing factor(s) of this type of events as part of product continuous improvement.As per capa the potential factors that might be leading to the intra-op fractures are: 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.Conclusion: the root causes of the reported cage crack cannot be confirmed due to lack of x-ray image and no product return.
Event or Problem Description
It is reported that the cage cracked and remained implanted.No adverse consequences to the patient has been reported.

• Brand Name: 14X28X12DEG-11
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7908531
• Report Number: 3004024955-2018-00046
• Device Sequence Number: 1449299
• Product Code: MAX
• UDI-Device Identifier: 07613327295900
• UDI-Public: 07613327295900
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 48953142
• Device Lot Number: D6P61
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1