MAUDE Adverse Event Report: STRYKER SPINE-US 7MM X 0DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48953070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
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 the "twist and distract" method, as the primary root cause.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 against using the ¿twist and distract¿ method.This event is still under investigation and a supplemental report will be submitted upon receipt of additional information and/or conclusion of the investigation.Misplaced during sterilization.
Event or Problem Description
It was reported that a tritanium pl cage fractured around the graft window during insertion at l2/l3 while the surgeon was performing a "twist and distract" method of insertion.There were no adverse consequences to the patient.The procedure was completed successfully with a 5 minute surgical delay.
Additional Manufacturer Narrative
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, and no relevant manufacturing issues or similar complaints were identified.Through a capa performed in 2017, the following have been deemed root causes for intra-op fracture: thickness of wall adjacent to lateral window; size of lateral window; user overestimating strength of implant and applying excessive force (torsional, cantilever); user not following surgical technique guide ¿ recommendation to distract prior to insertion, ¿twist & distract¿ method, inadequate disc prep, lack of trailing; using oversized implant or wrong type/size of inserter, not distracting when inserting or repositioning.It was reported that the cage was rotated while in the disc space.This was determined to be a contributing root cause during the capa investigation.Additionally, the stg warns against rotating the cage within the disc space.
Event or Problem Description
It was reported that a tritanium pl cage fractured around the graft window during insertion at l2/l3 while the surgeon was performing a "twist and distract" method of insertion.There were no adverse consequences to the patient.The procedure was completed successfully with a 5 minute surgical delay.

• Brand Name: 7MM X 0DEG 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: 11141668
• Report Number: 3004024955-2021-00001
• Device Sequence Number: 3698142
• Product Code: MAX
• UDI-Device Identifier: 07613327117837
• UDI-Public: 07613327117837
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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 Expiration Date: 03/04/2021
• Device Model Number: 48953070
• Device Catalogue Number: 48953070
• Device Lot Number: AE04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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