MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 2 LEVEL ACP SIZE 30MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	48651230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; locking ring on product broke upon screw insertion.Dr.Did not over angle screws.Two plate malfunctioned in same case.
Additional Manufacturer Narrative
Per surgical technique, "both the fixed and the variable guide instrument direct the screw trajectory within the range that ensure optimal functioning of the locking ring.The fixed guides are rigidly attached to the plate at 8 degrees of sagittal angulation in the end holes (neutral axis) and 0 degrees of sagittal angulation in the middle holes.The tip design of the variable guides allows for a range of sagittal angulation from +/- 6 degrees in all screw holes.Positioning the bone screws within the allowed range of angulation will ensure secure locking of the screws within the plate." root cause is that the trajectory of the screws was too steep.
Event or Problem Description
It was reported that; locking ring on product broke upon screw insertion.Dr.Did not over angle screws.2 plate malfunctioned in same case.The surgery was successfully completed using a longer plate with a one hour delay.There are no reports of adverse health consequences to the patient.

• Brand Name: REFLEX-HYBRID 2 LEVEL ACP SIZE 30MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7180376
• Report Number: 0009617544-2018-00008
• Device Sequence Number: 13941197
• Product Code: KWQ
• UDI-Device Identifier: 04546540534804
• UDI-Public: (01)04546540534804
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K063430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48651230
• Device Catalogue Number: 48651230
• Device Lot Number: 176227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 107