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

Catalog Number 48644014

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  malfunction  

Event Description

It was reported that; the screw of the patient who performed cervical vertebra anterior fusion surgery for c4-5 in (b)(6) 2017 backed out.

Event Description

It was reported that; the screw of the patient who performed cervical vertebra anterior fusion surgery for c4-5 in 2017/8/29 backed out.

• Brand Name: REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7049812
• MDR Text Key: 93310836
• Report Number: 0009617544-2017-00415
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K040261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48644014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1