MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATOR UPLIF SPACER 11MM X 26MM X 4DEG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48392114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a navigator uplif spacer broke upon insertion, ¿due to tight disc space.¿ the surgery was successfully completed using a cage which was 2 mm shorter after a 3-minute surgical delay.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual inspection confirmed the cage fractured.Device and complaint history records were reviewed for the provided lot number and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: the disc space height can be sized using a series of paddle distractors, reamer distractors or trials.The paddle distractor, reamer distractor, or trial size is serially increased until the appropriate fit within the disc space is achieved.The paddle distractor, reamer distractor, or trial should fit snugly within the disc space with distraction released, but care must be taken to not oversize the implant.Under-sizing may contribute to loss of lordosis and inadequate stability for fusion, while over-sizing may result in difficulty inserting the implant and disruption of the vertebral boney endplate with subsequent graft subsidence.Continue to impact gently and progressively into the disc space until the implant reaches desired positioning.Note: if difficulty is encountered, it most likely represents a mechanical block to the passage of the implant.Check for adequacy of the discectomy and be sure distraction is maintained.Then, reposition the implant as needed.The distraction may be released slightly to facilitate final positioning.Root cause of reported event was determined to be multifactorial: tight disc space and incorrect implant size used.
Event or Problem Description
It was reported that a navigator uplif spacer broke upon insertion, ¿due to tight disc space.¿ the surgery was successfully completed using a cage which was 2 mm shorter after a 3-minute surgical delay.There was no adverse consequence to the patient.

• Brand Name: NAVIGATOR UPLIF SPACER 11MM X 26MM X 4DEG
• 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: 8875933
• Report Number: 0009617544-2019-00094
• Device Sequence Number: 11445821
• Product Code: MAX
• UDI-Device Identifier: 07613252252276
• UDI-Public: 07613252252276
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151726
• 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): 10/25/2019

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: Health Professional
• Device Catalogue Number: 48392114
• Device Lot Number: 187391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1