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U.S. Department of Health and Human Services

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

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 55840007560
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2016
Event Type  Malfunction  
Manufacturer Narrative

Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. Image review: submitted images appear to display mas separated from the bone screw, and two driver tips sheared off at the distal tip.

 
Event Description

It was reported during surgery, the pedicle screw broke when the surgeon tried to remove it. The product came in contact with patient. Fragments of the broken screw remained in patient. Patient complications are unknown.

 
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.

 
Event Description

Procedure: spondylodesis posterolateralis l5-s1, decompression at l5/s1 cum laminectomy no patient complications were reported as a result of the event.

 
Manufacturer Narrative

Product analysis: visual inspection confirms only the head assembly of the implant returned for analysis, with the (-01) bone screw component missing and not returned for analysis. The ring (-04) and crown (-03) were still assembled in the head. Microscopic examination of the (-04) ring identified ring id feature material displacement, enlarging the id, and the "ears" of the ring bent upward, thus reducing the mechanical retention of the bone screw head. The ring is noted to be fully seated in the retaining groove of the head. The above observations are consistent with mechanical overload as the mechanism of failure.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameCD HORIZON SPINAL SYSTEM
Type of DeviceORTHOSIS, 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 Key6212075
MDR Text Key63477181
Report Number1030489-2016-03602
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeFI
PMA/PMN NumberK113174
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/02/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number55840007560
Device LOT NumberH5156171
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/28/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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