MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	55840008570
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).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
Pre-op diagnosis: degenerative spinal disease and previous t11-pelvis fusion ((b)(6) 2015) procedure: revision pelvis screws to previous t11-pelvis fusion levels implanted: t11-pelvis it was reported that post-op, distal component of broken screws were too deep in pelvis to be removed.Movement was visible during surgery at s1/pelvis junction.The patient suffered from pain and hence a revision for the pelvic screws was done.Fragments of the product remained in the patient as distal component of broken screws could not be removed because they were too deep in pelvis to be removed without additional trauma to patient.
Additional Manufacturer Narrative
Image review: post-op images from t11 to iliac surgery shows fracture of the iliac and sacral screws bilaterally.There is a small l5-s1 interbody device with a paucity of bone graft at this level.The fracture of the iliac screw appears to be deep and difficult to remove, contributing factors include failure of fusion.Hardware placement and alignment appear satisfactory.Root cause: patient factors.
Additional Manufacturer Narrative
Product analysis: visual examination of the mas bone screw confirmed bone screw complete fracture at approximately ~8-9 threads from the base of the bone screw head.Optical examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation.Microscopic examination of the fracture surface identified gently curving convex striations through the cross sectional area of the implant, which are indicative of cyclic fatigue until subsequent mechanical failure of the implant.Dimensional inspection of major and minor diameter 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 implant components.The above observations are consistent with cyclic fatigue.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6165676
• Report Number: 1030489-2016-03392
• Device Sequence Number: 16362924
• Product Code: NKB
• UDI-Device Identifier: 00643169004450
• UDI-Public: 00643169004450
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/14/2017

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: 55840008570
• Device Lot Number: H5176195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 03/14/2017
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 12/14/2016; 03/16/2017; 09/27/2017
• 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: 70 YR
• Patient Weight: 73