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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 54740005535
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510k: this part is not approved for use in the united states; however a like device catalog # 54840005535, 510k # k091974 and udi # (b)(4) was cleared in the united states. Product analysis: visual and microscopic inspection revealed one of the upper threads on the saddle of the screw has been bent and cracked. Functional inspection with a sample set screw confirmed the screw would not engage and thread into the saddle of the screw. This type of damage is consistent with misalignment of the set screw during the engagement process. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient presented with burst fracture at l2; and underwent posterior spinal fusion at t11-l4. Intra-op, the reported screw could not be gripped to the screwdriver. The product could not be attached even though the sleeve was turned. Since other screws were able to be gripped with the same driver without any problems, it was considered that there was some problem with the thread of the head of the alleged pedicle screw. There seemed to be burrs on the screw. There were no patient complications reported as a result of this event.
 
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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 Key9914803
MDR Text Key186552172
Report Number1030489-2020-00406
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
Report Date 04/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number54740005535
Device Lot NumberH5471929
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2018
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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