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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 7049855
Medical Device Problem Codes Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code Pain (1994)
Date of Event 08/25/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product and product images 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 complained of pain due to which the patient wanted the screw to be removed.For which the patient underwent explant surgery on (b)(6) 2017.The set screw did not unscrew as being cold welded to the connector and metal cutting burs were used to cut the construct to remove the iliac screws.Patient issue has been resolved now.
 
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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 Key6881815
Report Number1030489-2017-02087
Device Sequence Number718276
Product Code KWP
UDI-Device Identifier00613994171108
UDI-Public00613994171108
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K040962
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/25/2017
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 Number7049855
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/25/2017
Initial Report FDA Received Date09/21/2017
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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