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

Catalog Number	859-550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	02/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
Pre-operative diagnosis: patient was suffering from back pain due to compression of cauda equina at the level l2 procedure: "lumbar open" it was reported that on unknown date, post-op, the implanted screw broke which caused severe back pain to the patient.Patient underwent revision surgery on an unknown date.Only a portion of the broken screw could be explanted and lower half of the screw still remains in the patient.
Additional Manufacturer Narrative
Add'l info product analysis: visual and optical examination of fas bone screw confirm breakage approximately ~4 threads from the base of the bone screw head, microscopic examination of the fracture surface noted significant secondary (post-fracture) smearing to the fracture surface.Undamaged areas of fracture surface revealed ratchet marks around the area of crack origination, with gently convex progressive striations beach marks through the cross sectional area consistent with cyclic fatigue.Dimensional examination of the major and minor diameter verified conformance to print specification.The above observations are consistent with cyclic fatigue.

• 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: 6423665
• Report Number: 1030489-2017-00579
• Device Sequence Number: 13728884
• Product Code: KWP
• UDI-Device Identifier: 00673978063478
• UDI-Public: 00673978063478
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K961633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2017

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 Number: 859-550
• Device Lot Number: 0242885W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Initial Date Received by Manufacturer: 02/25/2017
• Supplement Date Received by Manufacturer: Not provided; 04/26/2017
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 05/10/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 60