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 Codes	Pain (1994); Spinal Cord Injury (2432)
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.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 that the patient underwent transforaminal lumbar interbody fusion on l5/s (tlif) due to spinal canal stenosis.Post-op, the screw on the right side of sacrum s1 broke from the base.Cauda equina symptom and lower limb pain were developed to the patient as a result of this event.It is considered that bone union has not been achieved at l5/s.The patient underwent revision surgery for the removal of broken screw.
Additional Manufacturer Narrative
Product image review result: submitted images appear to display broken multi axial bone screw, with fracture located near the neck, just below the bone screw head.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: visual microscopic the bone screw has broken just under the head.The fracture face is almost completely smeared from the two pieces on the bone screw rubbing together and damage from what appears to have happened in the removal process.A microscopic review of the fracture face did not reveal signs of cyclic fatigue.The angle of the fracture is approx.45 degrees and is consistent with a sudden material overload.Witness marks on the saddle show that the rod was slightly angulated approx.90 degrees to the direction of the bone screw fracture.The above observations are consistent with material overload.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: 6975541
• Report Number: 1030489-2017-02243
• Device Sequence Number: 11051854
• 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): 05/17/2018

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: 04/12/2018
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 12/14/2017; 04/18/2018
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 12/29/2017; 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SET SCREW, ROD.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 75