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

Catalog Number	7576550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); 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
It was reported that patient presented with pre-op diagnosis as spondylolithesis (l5/s1).For which patient underwent, l5/s1 minimally invasive fusion using sextant reduction and capstone cage at levels l5/s1.On an unknown date, post-op, the implanted screw broke.Patient experienced pain due as a result of broken screw.The patient underwent revision surgery on (b)(6) 2017.Both s1 screws were replaced and new rods and set screws have been implanted.
Event or Problem Description
Procedure performed in the initial surgery: lumbar interbody fusion levels implanted in the initial surgery: l5/s1 right s1 screw fractured; evident on x-rays taken on (b)(6) 2016 there was no malfunction with the other screw but the surgeon replaced the other s1 screw as a pre-caution.Patient is doing well after revision surgery.
Additional Manufacturer Narrative
Additional information: product analysis results: visual review confirmed screw breakage approximately 4 threads down from the base of the multi-axial screw neck.Optical examination of the area of fracture initiation did not identify any pre-existing surface defect near the area of crack origination that could contribute to crack propagation.Significant fracture surface damage and smearing was noted.Microscopic examination of the undamaged portions of the fracture surface identified a fairly flat fracture surface with some evidence of ratchet marks near the area of crack propagation, and gently convex progressive striations through the cross-sectional area of the multi-axial screw, consistent with cyclic fatigue.Dimensional examination of the major and minor diameters of the bone screw confirmed that the relevant bone screw dimensions were within print specification.The above observations are consistent with cyclic fatigue.
Additional Manufacturer Narrative
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; mdt sofamor danek puerto rico; humacao PR
• MDR Report Key: 6445202
• Report Number: 1030489-2017-00710
• Device Sequence Number: 1200352
• Product Code: KWP
• UDI-Device Identifier: 00885074031170
• UDI-Public: 00885074031170
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K032265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/17/2017

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: 7576550
• Device Lot Number: H5195811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 05/31/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 05/05/2017; 06/27/2017; 10/17/2017
• 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: 50 YR
• Patient Weight: 93