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	54750017550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/07/2018
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
Initial surgery: tlif (transforaminal lumbar interbody fusion) was performed on l4/5/s reason for revision surgery: degenerative scoliosis revision surgery: olif (oblique lumbar interbody fusion) was performed on th10-s l1-4 it was reported that on an unknown date, patient underwent a tlif surgery in which a screw was implanted.Post-op, patient suffered with degenerative scoliosis due to which patient had to undergo a revision olif surgery.During the revision surgery, the screw broke when a sequential reducer was attached to its head.The screw head was extracted but the tip remained in the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Product analysis: the mas screw has broken at the neck just before the threads start.The bone screw is at max angulation and it appears from the witness marks on the saddle the rod was sitting at an angle.There are convexed striation through ~75%-85% of the material consistent with cyclic fatigue.The result of the failure appears to cyclic fatigue.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.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: 7662231
• Report Number: 1030489-2018-00955
• Device Sequence Number: 11420427
• Product Code: NKB
• UDI-Device Identifier: 00643169501119
• UDI-Public: 00643169501119
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 04/07/2023
• Device Catalogue Number: 54750017550
• Device Lot Number: H5176143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 07/04/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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