MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48644014
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
In (b)(6) 2018 the device was implanted.On review of x-ray during a post-operative check-up, the physician noted that a locking screw was "out of its place." the patient underwent revision surgery on (b)(6) 2019 during which the dislocated locking screw was removed.No adverse consequences to the patient were reported.
Event or Problem Description
In (b)(6) 2018 the device was implanted.On review of x-ray during a post-operative check-up, the physician noted that a locking screw was "out of its place." the patient underwent revision surgery on (b)(6) 2019 during which the dislocated locking screw was removed.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Visual, dimensional, functional and materials analysis could not be performed as the device was discarded by the hospital.Complaint history review for similar events and device history records could not be performed as a valid lot code was not provided and could not be obtained.A screw was reported to have migrated.Patient information along with pathologies and bone quality was not made available.The possible root causes of this range from: hard bone quality; guide/punch awl not used to prepare screw hole; screw hole too shallow; screw threads are worn/stripped; guide not used during screw insertion; screw over angulated.

• Brand Name: REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8516816
• Report Number: 0009617544-2019-00048
• Device Sequence Number: 1839449
• Product Code: KWQ
• UDI-Device Identifier: 04546540534682
• UDI-Public: 04546540534682
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K063430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: Health Professional
• Device Catalogue Number: 48644014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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