MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONSTRAINED, OVERSIZED SCREW 4.5X14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 186864014

Device Problem Device Slipped (1584)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision surgery for c5 corpectomy and fusion was performed (b)(6) 2017 at the alfred hospital.This was a revision procedure.Following the primary procedure, the plate 186801026 and 186864014 x 2 had pulled out of the c6 vertebral body 50 percent.The inferior part of 495.451 had also slipped anteriorly.In the primary procedure, the inferior part of the synmesh c was placed on the inferior endplate of the c5 vertebrae with the c5/6 disc below retained in addition.The synmesh c may have subsided.There was no identifiable issues with any of the implants upon removal.The revision was completed with a discectomy at c5/6 and c5 endplate removal at the level below and another synmesh c cage (rested on the inferior endplate of c4 and superior endplate of c6), skyline plate and screws were implanted.The plate was locked off as per the surgical technique.The surgeon was very pleased with the revision procedure.

Manufacturer Narrative

During initiation, the incorrect quantities were noted for this complaint.Parts that pulled out are (1) 1868-01-026 and (2) 1868-64-014.Part numbers 1868-60-014 (2) are concomitant.Complaint has been updated to reflect correct part numbers.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONSTRAINED, OVERSIZED SCREW 4.5X14MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6487030
• MDR Text Key: 72606567
• Report Number: 1526439-2017-10244
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 186864014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: HYBRID ONE LEVEL PLATE, 26MM
• Patient Outcome(s): Other; Required Intervention