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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Catalog Number 7226540
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
 
Event or Problem Description
Procedure: minimally invasive intersomatic arthrodesis levels of implant: l5-s1 it was reported that on an unknown date, post-op,the right sacral screw of s1 broke inside the patient and the distal part of this screw remains in the patient.A revision surgery was performed and the proximal part of the screw was explanted.Patient complications as a result of this revision surgery have been reported as unknown.
 
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Brand Name
CD HORIZON SPINAL SYSTEM
Common Device Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
MDR Report Key6306437
Report Number1030489-2017-00257
Device Sequence Number512388
Product Code KWP
UDI-Device Identifier00885074362892
UDI-Public00885074362892
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K050809
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2016
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/13/2017
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 Number7226540
Device Lot Number0178074W
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/13/2017
Initial Report FDA Received Date02/07/2017
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 Required Intervention;
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