MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 54740007555

Device Problem Break (1069)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that a transforaminal lumbar interbody fusion surgery at l3-s1 due to lumbar spinal canal stenosis and screws were inserted from l2 to s.Post-op, patient presented with pain.Upon inspection of various previous images it was noticed that screw placed at sacrum was broken.The broken screw was removed but its tip part was left in patient's body and screws were placed at l2 and s2ai for extension of fixation range.

Manufacturer Narrative

X-ray review: a single post op image is provided after l3-s1 posterior spinal fusion.This shows a fractured screw on the left at s1.Per the notation, bony fusion at l5/ s1 but had occurred at the lumbar levels.Failure of fusion is responsible for construct failure hardware placement at this level appears appropriate.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6215010
• MDR Text Key: 63607445
• Report Number: 1030489-2016-03604
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2019
• Device Catalogue Number: 54740007555
• Device Lot Number: H11E2819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR