MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATOR 9MM X 26MM X 4DEG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48392094
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded by the hospital.
Event or Problem Description
It was reported that the securing mechanism of an avs navigator peek cage fractured during insertion.The procedure was completed successfully without surgical delay using a back-up device.No implant fragments remain inside the patient.There were no adverse consequences to the patient.
Event or Problem Description
It was reported that the securing mechanism of an avs navigator peek cage fractured during insertion.The procedure was completed successfully without surgical delay using a back-up device.No implant fragments remain inside the patient.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was discarded.A review of the device and complaint history records could not be performed as a valid lot number was not provided and could not be obtained.From instructions for use: the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery.Per email correspondence, "there was no distraction on the disc space, the disc space was not tight, we used a 9mm shaver and were attempting to insert a 9mm cage.A small mallet was used, there were no fragments left in patient,straight navigator inserter was used, dr smith just lightly tapped the insertor." since the device was not returned, root cause could not be determined but potentially due to following factors: implant is not firmly attached to inserter prior to impaction; user applies too much axial/impaction/cantilever force; user applies a torque; incorrect implant size chosen; user misaligns insertion of implant; endplate/vb damage during trialing step; insufficient visibility at wound site; implant disengages from inserter during impaction.

• Brand Name: NAVIGATOR 9MM 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: 8947232
• Report Number: 0009617544-2019-00097
• Device Sequence Number: 11300482
• Product Code: MAX
• UDI-Device Identifier: 07613252252221
• UDI-Public: 07613252252221
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/05/2019

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: 48392094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 140