MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	75446540
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).Product was not 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 on an unknown date, post-op, the implanted screw broke after 6 months.The patient underwent a revision surgery for removal.
Additional Manufacturer Narrative
Product image review: submitted image appears to display broken bone screw.X-ray review: post-op x-rays from l3-s1 posterior spinal instrumentation show fracture of one of the sacral screws.No interbody grafts are present and there is a paucity of graft present laterally.Failure of the bony fusion is the likely reason as most of the lumbar placement appears appropriate.
Additional Manufacturer Narrative
Product analysis: visual review confirms screw breakage approximately ~1 thread down from the base of the bone screw head.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.Fracture surface damage is noted.Microscopic examination of the undamaged portion of the fracture surface identified a fairly flat fracture surface with gently convex progressive striations through the cross-sectional area of the bone screw, consistent with cyclic fatigue.Dimensional examination of the major diameter of the bone screw confirms relevant bone screw dimensions are within print specification.The above observations are consistent with 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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6705059
• Report Number: 1030489-2017-01736
• Device Sequence Number: 11225951
• Product Code: KWP
• UDI-Device Identifier: 00885074134116
• UDI-Public: 00885074134116
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2017

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: 75446540
• Device Lot Number: H5214582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 07/11/2017; 09/11/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 07/18/2017; 09/12/2017
• 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