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
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital disposed of device.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3004024955-2021-00021
• Device Sequence Number: 12113318
• Product Code: MAX
• UDI-Device Identifier: 07613327117349
• UDI-Public: 07613327117349
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Race: Asian