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

Catalog Number	7571110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
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
Level implanted- l3-s1 it was reported that on an unknown date,post-op, the rod was broken for which an explant surgery was performed on (b)(6) 2016.The broken rod was completely explanted in the revision surgery.No patient complications were reported.
Additional Manufacturer Narrative
Analysis: visual review confirms rod breakage.Damage and smearing noted on fracture surfaces.No immediately adjacent pre-existing surface defects identified that could contribute to crack propagation of fracture.Significant deformation at multiple locations along the length of rods due to apparent rod bending.Fracture surface examination of the fractured rods identified ratchet marks near the origin of crack propagation, with progressive striations or beach marks emanating through the cross section of the rods until subsequent mechanical failure.Dimensional inspection confirms conformance to print specification.After visual, optical and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implants.The above observations are consistent with failure due to cyclic fatigue.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: 6741144
• Report Number: 1030489-2017-01818
• Device Sequence Number: 983504
• Product Code: KWP
• UDI-Device Identifier: 00613994303103
• UDI-Public: 00613994303103
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K052747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

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: 7571110
• Device Lot Number: 0262052W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 09/11/2017
• 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: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 112