MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7226545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date: only year valid.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 on an unknown date in 2016, the patient underwent l4-l5 stabilization and l5-s1 fusion decompression, in which the rods and screws were implanted.On an unknown date, post-op, the reported screw at s1 broke.The patient also suffered from adjacent level degeneration.Hence, on (b)(6) 2019, a revision surgery was performed, in which the head of the screw was removed while the tip remains implanted in patient's s1 vertebra.No injury to the patient has been reported after the revision surgery.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the revision surgery, removal of previous instrumentation and re-fusion was performed.
Additional Manufacturer Narrative
Product analysis: visual review confirms screw breakage approximately 5 threads down from the base of the bone screw neck.Visual and optical examination of the area of fracture initiation did not identify a pre-existing surface defect near the area of crack origination that could contribute to crack propagation.Microscopic examination of the fracture surface identified a rigid angulated fracture on one side and the other side's surface is very smooth consistent with rubbing contact overtime.Dimensional examination of the major diameter of the bone screw confirmed relevant bone screw dimensions are within print specification.Unable to determine root cause of break dew to the condition of the fracture surface.If information is provided in the future, a supplemental report will be issued.

• 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 Key: 9139488
• Report Number: 1030489-2019-01098
• Device Sequence Number: 14148795
• Product Code: KWP
• UDI-Device Identifier: 00885074362908
• UDI-Public: 00885074362908
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K182928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2019

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 Number: 7226545
• Device Lot Number: 0297409W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/22/2019; 12/10/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/20/2019; 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RODS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR