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

Catalog Number	55750015540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent screw removal surgery at l2 due to bone union had achieved.Intra-op, screw on the left side of l2 had broken during removing the screw as the bone union achieved.Fragments of the implant were remaining in the patient.No patient complications were reported due to this event.
Additional Manufacturer Narrative
Correction: initial reporter.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis results: visual review confirms screw breakage approximately 5 threads down from the base of the bone screw neck.Visual and 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.Optical examination revealed witness marks on the crown of the screw where the rod was seated.Microscopic examination of the fracture surface identified a fairly flat fracture surface with circular material flow, consistent with torsional overload.Dimensional examination of the major diameter of the bone screw confirmed relevant bone screw dimensions are within print specification.This type of damage is consistent with torsional overload during the removal process.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA VOYAGER 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: 9213161
• Report Number: 1030489-2019-01184
• Device Sequence Number: 2483871
• Product Code: NKB
• UDI-Device Identifier: 00643169783768
• UDI-Public: 00643169783768
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2025
• Device Catalogue Number: 55750015540
• Device Lot Number: H5374010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 09/21/2019
• Supplement Date Received by Manufacturer: 11/02/2019; 01/02/2020
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/01/2019; 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1