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	54750017545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not 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 patient was presented with l4 burst fracture and underwent spinal fusion procedure.Post-op, the screw at the right side of l5 was broken.Patient underwent revision surgery for removal of the screw.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Post op x-rays and ct for l3-5 minimally invasive pedicle screw fixation for l4 burst fracture.Presumably this instrumentation was placed as an internal brace for the fracture/ no interbody graft was present and we would not expect bony fusion across 3 vertebral bodies.External hardware failure is expected with this construct given the biomechanical mobility of the spinal segment in a young patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: no immediately adjacent pre-existing surface defects identified that could contribute to crack propagation of fracture.Fracture surface examination of the fractured screw identified progressive striations or beach marks through the cross-section of the rods until subsequent mechanical failure.The fracture does appear to be the result of cyclic fatigue.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: 7081858
• Report Number: 1030489-2017-02443
• Device Sequence Number: 1399300
• Product Code: NKB
• UDI-Device Identifier: 00643169501126
• UDI-Public: 00643169501126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143375
• 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): 04/16/2018

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 Expiration Date: 09/01/2023
• Device Catalogue Number: 54750017545
• Device Lot Number: H5212090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/12/2018; 04/09/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 01/25/2018; 04/16/2018
• 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: 25 YR