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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 54740007545
Device Problems Device Inoperable (1663); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2017
Event Type  malfunction  
Manufacturer Narrative
This part is not approved for sale in us, but a similar device with catalog# 54840007545 and 510k# k091974 and udi# (b)(4) is approved for sale in the us. Product image review: submitted images appeared to display damaged multi axial screw head. The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event. 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
It was reported that on (b)(6) 2017 the patient underwent transforaminal interbody lumbar fusion at l4/s. Intra-op, after the rod was placed with rod reduction plier in the head of multi axial screw in the left side of l4, counter torque couldn¿t be placed on the screw because the head was widened. The set screw insertion was tried without counter, but failed. The set screw could not be tightened because the screw head was widened. So, the rod was removed and the relevant screw was replaced with new one. The procedure was completed without any further problem. No fragment of the implant remained in the patient. No patient complications were reported as a result of this event.
 
Manufacturer Narrative
Product analysis: the witness marks on the saddle indicate that the rod was seated at some point. There was damaged to the splayed side of the head notably in two locations, one is near the slot that locates the inserter/rod reducer, the other is the first thread at the top of the head is chipped, on that same side. It appeared that some type of instrument was used to grab the head and bend it outward. The screw would accept both the go and the no/go gauges, this was not a surprise as the head was visibly splayed.
 
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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
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6766253
MDR Text Key81940281
Report Number1030489-2017-01859
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number54740007545
Device Lot NumberH5365016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2017
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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