MAUDE Adverse Event Report: STRYKER SPINE-US 10MM X 6DEG X 11MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48955106
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital discarded.
Event or Problem Description
It was reported that a tritanium pl cage at l4/5 migrated approximately 9 months post-operatively.During revision surgery to remove the cage, it was noticed there was also a loose trio pedicle screw which subsequently was removed.The patient hadn't fused and was experiencing pain.This report captures the cage.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was discarded by the hospital.However, x-rays were reviewed and non-union was confirmed.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The surgical technique guide was reviewed and the following was found to be relevant: delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.If a nonunion develops or if the implants loosen, bend or break, the device(s) must be revised or removed immediately before serious injury occurs.The most likely cause of the reported event was determined to be due to the delayed healing and non-union reported after 10 months.
Event or Problem Description
It was reported that a tritanium pl cage at l4/5 migrated approximately 9 months post-operatively.During revision surgery to remove the cage, it was noticed there was also a loose trio pedicle screw which subsequently was removed.The patient hadn't fused and was experiencing pain.This report captures the cage.

• Brand Name: 10MM X 6DEG X 11MM X 28MM
• 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: 12229682
• Report Number: 3004024955-2021-00020
• Device Sequence Number: 1481339
• Product Code: MAX
• UDI-Device Identifier: 07613327118087
• UDI-Public: 07613327118087
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48955106
• Device Catalogue Number: 48955106
• Device Lot Number: ELM6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2018
• 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