MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK TRITANIUM PL 9MM X 28MM X6DEG - 11MM POSTERIOR LUMBAR CAGE; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number 48955096

Device Problems Break (1069); Fracture (1260); Split (2537); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2016

Event Type  malfunction  

Event Description

It was reported that the doctor was inserting the cage into the disc space.He was malleting the cage in and the cage split in half.Half the cage was in the disc space and half was still on the inserter.Normal steps were taken to prepare the disc space; shavers, paddles, and trials.After some time, the cage was able to be removed from the space, and the same size cage was inserted in without any problem, after distraction off the screws.

Manufacturer Narrative

Method: visual inspection; device history review; complaint history review; risk assessment; results: the device was sent for a material analysis and it was determined that it fractured in bending overload due to an applied force during implantation.The surgical technique advises the user to adequately distract the space and to use various trials and other instrumentation to ensure the disc space is adequately prepared.It was confirmed that after the breakage occurred, the space was distracted off of the screws and a replacement cage was placed without issue.Correspondence with the sales rep confirmed that distraction off of the screws was not performed initially and that the space was "pretty tight." conclusion: this suggests that the most likely cause of the customer reported event is inadequate distraction of the disk space prior to insertion.

Event Description

It was reported that the doctor was inserting the cage into the disc space.He was malleting the cage in and the cage split in half.Half the cage was in the disc space and half was still on the inserter.Normal steps were taken to prepare the disc space; shavers, paddles, and trials.After some time, the cage was able to be removed from the space, and the same size cage was inserted in without any problem, after distraction off the screws.

• Brand Name: TRITANIUM PL 9MM X 28MM X6DEG - 11MM POSTERIOR LUMBAR CAGE
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5613552
• MDR Text Key: 44488530
• Report Number: 3004024955-2016-00047
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48955096
• Device Lot Number: A8X3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1