MAUDE Adverse Event Report: STRYKER SPINE-US CURVED POSTERIOR LUMBAR CAGE 31X10X9X12 DEG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48932092
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that after intra-operative placement of a tritanium tl cage, the implant 'dropped into the body'.A second surgical incision was needed in order to retrieve the implant.After retrieval the original implant was placed again and remains in the patient.
Event or Problem Description
It was reported that after intra-operative placement of a tritanium tl cage, x-ray images revealed that the cage was beyond the anterior border of the vertebral body.The patient was then flipped and a second surgical incision was made to explant the cage using an anterior approach.An alif cage was then placed.
Additional Manufacturer Narrative
Additional information has been received and sections b5 and h3 have been updated.H3 other text : status and location of the device is unknown.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.Per the additional information, the cage was placed with non-steerable inserter, the implantation angle was not difficult and the surgeon did not appear to use complex maneuvers or excessive forces during the procedure.Tritanium tl ifu and surgical technique steps for implant insertion was reviewed: ¿align the threaded distal tip of the inner shaft with the threaded hole on the selected cage.Secure the cage to the inserter by turning the back locking knob on the inserter clockwise until the implant is tightly connected.Ensure the inserter is properly connected to the implant and there are no voids between the inserter and implant.¿ note: ¿fluoroscopy may be useful in determining the appropriate trajectory for insertion of the cage and appropriate final positioning.Care should be taken to avoid violation of the anterior annulus.¿ based on the correspondence with the rep, incorrect implant placement was due to user releasing the cage from the inserter before confirming satisfactory position with x-ray.
Event or Problem Description
It was reported that after intra-operative placement of a tritanium tl cage, x-ray images revealed that the cage was beyond the anterior border of the vertebral body.The patient was then flipped and a second surgical incision was made to explant the cage using an anterior approach.An alif cage was then placed.

• Brand Name: CURVED POSTERIOR LUMBAR CAGE 31X10X9X12 DEG
• 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: 13870016
• Report Number: 3004024955-2022-00002
• Device Sequence Number: 17322527
• Product Code: MAX
• UDI-Device Identifier: 07613327369113
• UDI-Public: 07613327369113
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2022

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: 48932092
• Device Catalogue Number: 48932092
• Device Lot Number: H11JH1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 04/15/2022; 06/29/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/11/2022; 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2018
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female