MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48950096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital retained device.
Event or Problem Description
It was reported that a tritanium pl cage fractured intra-operatively during in situ cage placement at l5-s1.There were no adverse consequences to the patient and all the fractured pieces were removed from the surgical site.The procedure was completed successfully with a 25 minute surgical delay by using an alternatively available cage.
Event or Problem Description
It was reported that a tritanium pl cage fractured intra-operatively during in situ cage placement at l5-s1.The representative reported that the disc space was not distracted and trialing was not performed prior to implant placement.There were no adverse consequences to the patient and all the fractured pieces were removed from the surgical site.The procedure was completed successfully with a 25 minute surgical delay by using an alternatively available cage.
Additional Manufacturer Narrative
A non-conformance was previously initiated to investigate the root cause associated with this failure mode.The investigation identified surgical techniques not included in the approved ifu, including adding precautions to not use the implant as the sole method for distraction (page 8).Stryker initiated a field safety corrective action on 28 november 2018 and notification was sent to the impacted customers.The surgical technique was updated to caution against misuse; this included an explicit warning of "do not use the implant as the sole method for distraction, as this may cause damage to the implant".Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was reported that the disc space was not distracted and trialing was not performed, both of these have been identified as probable causes for tritanium pl cage fractures.

• Brand Name: 9MM X 6DEG X 9MM X 23MM
• 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: 10819823
• Report Number: 3004024955-2020-00044
• Device Sequence Number: 1137857
• Product Code: MAX
• UDI-Device Identifier: 07613327117318
• UDI-Public: 07613327117318
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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 Model Number: 48950096
• Device Catalogue Number: 48950096
• Device Lot Number: K5N6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 81587
• Patient Sequence Number: 1