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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDIC, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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WARSAW ORTHOPEDIC, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 1606200500
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/06/2018
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
It was reported that the patient underwent pediatric scoliosis deformity correction surgery.Post-op, the rod came completely out of the closed head tulip.No fusion could be achieved due to this event.Hence, on (b)(6)2018, the patient underwent a revision surgery in which the rod was replaced.
 
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Brand Name
CD HORIZON SPINAL SYSTEM
Common Device Name
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
WARSAW ORTHOPEDIC, INC
2500 silveus crossing
warsaw IN 46582
MDR Report Key7917624
Report Number1030489-2018-01305
Device Sequence Number11278620
Product Code NKB
UDI-Device Identifier00643169319462
UDI-Public00643169319462
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
K131321
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/28/2018
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 Number1606200500
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/04/2018
Initial Report FDA Received Date09/28/2018
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;
Patient Age16 YR
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