MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 48955096

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2020

Event Type  malfunction  

Event Description

It was reported that two tritanium pl cages fractured intra-operatively during impaction.This contributed to an unknown surgical delay.This report captures the first of two cages.

Event Description

It was reported that two tritanium pl cages fractured at l5-s1 intra-operatively during impaction.This contributed to a 20 minute surgical delay.There were no adverse consequences to the patient and all fractured fragments were removed from the surgical site.This report captures the first of two cages.

Manufacturer Narrative

B5 has been updated to reflect the approximate surgical delay.Upon visual inspection it was noted that the cage was returned fractured in 2 pieces.One of the window supports is fractured away from the center line.The rear of the cage fractured near the rear window.Window of the cage appears to have been compressed.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.The tritanium pl surgical technique guide (stg) indicates that a cage should be chosen which is equivalent to the final trial height or final distractor used.The implant sizing is based on the fit and feel of either the final trial or distractor.A corrective action/preventative action was opened to further investigate and prevent recurrence of tritanium pl cage fractures.The root cause was determined to be the user overestimating the strength of the implant or not following the surgical technique which recommends to distract prior to insertion and warning against the ¿twist & distract¿ method, inadequate disc prep, and lack of trialing.It was reported that the disc space was distracted using shavers only, trialing was not performed and the disc space was tight.No twist and distract was performed, just slight canterlevering and sweeping.It was considered a difficult angle at l5/s1 with no difficulty with impaction or insertion.Implant was not repositioned.Compression was not applied to the disc space after insertion.Bone quality and patient factors are unknown.All pieces were retrieved from the patient.Trialing is a step outlined in the tritanium pl stg.The stg also warns against cantilevering the implant during insertion.Most likely root cause is multifactorial with lack of trialing, disc space too tight for the implant size selected and cantilever force applied during insertion contributing to the event.

• Brand Name: 9MM X 6DEG X11MM X 28MM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10417578
• MDR Text Key: 203307129
• Report Number: 3004024955-2020-00017
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07613327118070
• UDI-Public: 07613327118070
• Combination Product (y/n): N
• PMA/PMN Number: K181014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2022
• Device Model Number: 48955096
• Device Catalogue Number: 48955096
• Device Lot Number: D5NJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1