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 Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage was fractured while removing to reposition it into l5/s1 disc space.All broken fragments were removed.Surgical delay of 45 minute was reported.The surgery was completed using another cage of identical size.No adverse consequences to the patient was reported.
Additional Manufacturer Narrative
Method: product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via email correspondence.Device was not returned, therefore, the device evaluation could not be performed.Manufacturing history review was performed on the reported lot# no manufacturing related issue was found.It was reported that the cage fractured when a slap hammer applied to back it out for reposition.The cage was inserted at an oblique angle using a heavy hammer.The surgeon noticed the cage had twisted so attempted to twist before being told to stop.Conclusion: due to the lack of information and without returned device, when the cage was fractured cannot be determined.However, the cage fracture is likely due to either over twisting during insertion or over-impaction during removal for reposition.
Event or Problem Description
It was reported that the cage was fractured while removing to reposition it into l5/s1 disc space.All broken fragments were removed.Surgical delay of 45 minute was reported.The surgery was completed using another cage of identical size.No adverse consequences to the patient was reported.

• 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: 8292363
• Report Number: 3004024955-2019-00003
• Device Sequence Number: 19310737
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: 07613327118087
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K152304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: D5NK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1