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	54750017540
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on the patient underwent transforaminal lumbar interbody fusion at l5/s1 using screw and another manufacturer's cage.Post-op,the patient developed nerve root stenosis due to lateral out of the cage.The cause of the lateral out of the cage was that the insertion point of the s1 screw was on the cranial side, and the screw had cut out when inserting it, so the screw loosened and lateral out of the cage occurred.The patient had achieved solid fusion.The patient underwent revision surgery for removal of the cage and replacement of loosened screw.Because the screw cut out, the screw was replaced with a bigger one with changing insertion point.
Additional Manufacturer Narrative
Product analysis: the bone screw has returned with no visible signs of failure.Visual and microscopic examination does not reveal a failure of the screw.The major diameter of the bone screw appears to be to print spec.There does not appear to be a failure with the screw that would cause it to back out.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: 7499220
• Report Number: 1030489-2018-00655
• Device Sequence Number: 144461
• Product Code: NKB
• UDI-Device Identifier: 00643169501133
• UDI-Public: 00643169501133
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: 01/08/2026
• Device Catalogue Number: 54750017540
• Device Lot Number: H5407040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 08/15/2018
• 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: 69 YR