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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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WARSAW ORTHOPEDICS CD HORIZON; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Catalog Number 75446545
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code 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.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Procedure used: arthrodesis lumbar levels: l4-l5 it was reported that on an unknown date, post-op, the screws broke.Patient reported back pain due to the event.The screws were explanted in the revision surgery.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The broken implants were extracted and new ones were placed in the revision surgery.
 
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Brand Name
CD HORIZON
Common Device Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
MDR Report Key8463394
Report Number1030489-2019-00345
Device Sequence Number13788485
Product Code KWP
UDI-Device Identifier00885074134123
UDI-Public00885074134123
Combination Product (Y/N)N
Initial Reporter CountryUY
PMA/510(K) Number
K042025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 04/26/2019
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 Number75446545
Device Lot Number0641378W
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/08/2019
Supplement Date Received by Manufacturer04/23/2019
Initial Report FDA Received Date03/29/2019
Supplement Report FDA Received Date04/26/2019
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;
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