MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C DIAM.3.5MM SELF DRILLING 12MM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	48335312
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one month post operation, a film showed that a screw backed out.There were no issues during the four level fusion case and the surgeon was able to seat the screw past the black ring around the screwdriver into the cage inserter.Upon follow up with the surgeon, the patient is doing well.
Event or Problem Description
It was reported that one month post operation, a film showed that a screw backed out.There were no issues during the four level fusion case and the surgeon was able to seat the screw past the black ring around the screwdriver into the cage inserter.Upon follow up with the surgeon, the patient is doing well.
Additional Manufacturer Narrative
The patient underwent revision surgery to replace the screw with a rescue screw.There were no complications during the revision surgery.The x-ray images of the reported event were provided and confirmed screw migration.The device was not returned for evaluation as it was discarded at the hospital, therefore visual and functional inspection could not be performed.The lot # was not provided therefore the device history review and the complaint history review cannot be performed.The surgeon provided additional information about the initial surgery: the inserter was used however he may have taken off the inserter during the procedure to get more torque when inserting the screw, unsure if the black line (laser marking on the inserter) went beyond indicated area, the screw may have been inserted at difficult angle.The surgeon reiterated that the patient could not walk prior to the surgery but now started walking.Anchor c surgical technique (stg) indicates that a screw is locked when the gold color and the black line are no longer visible.Furthermore stg indicates that driving the black line beyond the indicated area may lead to screw and/or cage deformation.Stg indicates that excessive pivoting or angulation on the screwdriver while attached to the screw should be avoided as it can cause damage to the screwdriver and/or screw.Stg indicates to ensure proper depth and adequate locking when using the awl, drilling, or locking bone screws, use of a free hand technique is strongly discouraged.Use of the guide/inserter tip or low profile inserter is required.Per what was reported, the inserter may have been taken off to accommodated for difficult insertion angle.The root causes of the reported event is most likely multifactorial: excessive pivoting or angulation on the screwdriver while attached to the screw to accommodate for difficult insertion angle, not using the inserter throughout the entire procedure, and overtightening the screw.These factors may have resulted in improper seating of the screw and cause migration over time.Furthermore post-op activity level and life style may have contributed to the reported event.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 12MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7474269
• Report Number: 3005525032-2018-00031
• Device Sequence Number: 10846048
• Product Code: OVE
• UDI-Device Identifier: 04546540679840
• UDI-Public: (01)04546540679840
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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: 48335312
• Device Catalogue Number: 48335312
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 07/13/2018
• 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