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

Catalog Number	55410006545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient underwent an unspecified spinal procedure for stabilization of l4-l5.Post-op, the screw broke and the patient underwent a revision surgery.The distal parts of the screws remained inside the patient.
Additional Manufacturer Narrative
Corrected/ additional information.
Event or Problem Description
No patient complications were reported post revision surgery.
Additional Manufacturer Narrative
Product analysis :visual and optical examination of fas bone screw confirm breakage approximately 6 threads from the base of the bone screw head.Visual and optical examination of the adjacent surfaces to the area of crack propagation do not identify a surface defect which could contribute to the foregoing fracture.Optical and microscopic examination reveals significant secondary (post-fracture) damage to the fracture surface.Undamaged areas of fracture surface display progressive convex striations and beach marks through the cross-sectional area of the bone screw, until subsequent mechanical failure.Dimensional examination of the major diameter verified conformance to print specification.The above observations are consistent with cyclic fatigue.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: 6342656
• Report Number: 1030489-2017-00341
• Device Sequence Number: 30394
• Product Code: NKB
• UDI-Device Identifier: 00643169073999
• UDI-Public: 00643169073999
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2017

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: 55410006545
• Device Lot Number: H5251640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 03/02/2017; 04/21/2017
• 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