Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Catalog Number 55840018500
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
 
Event or Problem Description
It was reported that patient was pre-operatively diagnosed with non union at l5/s1 and l4/l5 and underwent posterior spinal fusion.Post op, screw was broken.Pain and non-union were reported as a result of the event.A revision surgery was performed to explant the screw.No fragments remained inside the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CD HORIZON SPINAL SYSTEM
Common Device Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
MDR Report Key7150485
Report Number1030489-2017-02574
Device Sequence Number1485966
Product Code KWP
UDI-Device Identifier00643169075740
UDI-Public00643169075740
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K113174
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number55840018500
Device Lot NumberH13E1375
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/05/2017
Initial Report FDA Received Date12/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
-
-