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

Catalog Number	55840006540
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).The product is not returned to manufacturer for evaluation but x-ray were reviewed.X-ray review: "post op x-rays from l5-s1 posterior spinal stabilization of an (b)(6) year old patient with spondylolisthesis show a fracture of one of the s1 screws.Fusion status is unknown but suspect failure of fusion/poor bone quality in this overweight and elderly patient as a contributing factor." 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.
Event or Problem Description
It was reported patient with pre-operative diagnosis of spondylolisthesis l5-s1 with spondylarthrosis underwent an unspecified spinal procedure at l5-s1.On an unknown date, post-op, the screw was found broken.Patient had pseudoarthrosis and back pain as a result of which this patient underwent an additional surgery to replace the broken screw and implant a cage.No fragments of the broken screw remained in patient.After revision surgery patient is fine.
Additional Manufacturer Narrative
Product analysis: visual examination of the mas bone screw confirmed bone screw complete fracture at approximately 2 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.Optical examination of the fracture surface noted significant fracture surface smearing.Microscopic examination of the undamaged portion 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
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: 6207955
• Report Number: 1030489-2016-03525
• Device Sequence Number: 415979
• Product Code: NKB
• UDI-Device Identifier: 00613994971746
• UDI-Public: 00613994971746
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113174
• 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): 01/30/2017

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: 55840006540
• Device Lot Number: H5244700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided; 01/30/2017
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 01/30/2017; 09/28/2017
• 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: 80 YR
• Patient Weight: 85