MAUDE Adverse Event Report: STRYKER SPINE-US POSTERIOR LUMBAR CAGE 8MM X 23MM X6DEG - 9MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 48950086

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Hospital disposed of device.

Event Description

It was reported that during placement of a tritanium pl cage intra-operatively, the positioning of the implant was not optimal.The implant "pulled out to the ventral side".To remove the mispositioned cage, the patient was operated on laterally.The event resulted in a 60 minute surgical delay for the additional surgery required.

Event Description

It was reported that during placement of a tritanium pl cage intra-operatively, the positioning of the implant was not optimal.The implant "pulled out to the ventral side".To remove the mispositioned cage, the patient was operated on laterally.The event resulted in a 60 minute surgical delay for the additional surgery required.

Manufacturer Narrative

Visual, dimensional, functional and material analysis could not be performed as the device was disposed by the customer.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The surgical technique provides the proper steps for sizing, trailing, and inserting the implants for when distraction is released, along with the steps to remove the implant if necessary.Per additional correspondence with the field, it is unknown how the disc space was distracted/prepped, if compression was applied to disc space after cage insertion, or if trailing was performed.Operative notes, photos and x-rays were not available.As further information about the case was not provided, a definite cause cannot be determined.Possible causes include excessive tamping during insertion, improper sizing/trailing/distraction, and/or poor patient bone quality.

• Brand Name: POSTERIOR LUMBAR CAGE 8MM X 23MM X6DEG - 9MM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12239868
• MDR Text Key: 263877117
• Report Number: 3004024955-2021-00021
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07613327117349
• UDI-Public: 07613327117349
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48950086
• Device Catalogue Number: 48950086
• Device Lot Number: E4K5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Race: Asian