MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X 9MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	48950096
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned per hospital policy.
Event or Problem Description
Primary surgery using es2 system was performed (b)(6) 2017.It was reported that the screw deviated from the vertebral body postoperatively and the cage fractured at l3/4.Patient was revised on (b)(6) 2019.This record represents the screw.
Event or Problem Description
Primary surgery using es2 system was performed (b)(6) 2017.It was reported that the screw deviated from the vertebral body post- operatively and the cage fractured at l3/4.Patient was revised on (b)(6) 2019.This record represents the cage.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed no relevant issues or similar events were identified.According to the ifu, ¿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.¿ as the cage was not returned, a definite root cause cannot be determined.However, the cage was implanted for almost two years and it is unknown if the patient fused.It was reported that one of the pedicle screws migrated out of position.This can cause instability in the construct which can put excess force onto the cage and possibly cause it to fracture.H3 other text : device was not returned and therefore could not be evaluated.

• Brand Name: 9MM X 6DEG X 9MM X 23MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8724911
• Report Number: 3004024955-2019-00025
• Device Sequence Number: 19253735
• Product Code: MAX
• UDI-Device Identifier: 07613327117318
• UDI-Public: 07613327117318
• Combination Product (Y/N): N
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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: No Information
• Device Catalogue Number: 48950096
• Device Lot Number: D58E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention