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	54750016540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Type of Reportable Event	Serious Injury
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 oblique lateral interbody fusion (olif) of 3 intervertebral discs at l2-3, l3-4, l4-5 due to unknown reason.Post-op, the screw loosening had occurred.Hence on (b)(6) 2019, revision surgery was performed and the screws at l2-3-4-5 were removed and replaced and fusion for extending was performed up to s1, s2ai.The patient complaints about pain between l4 and l5 intervertebral disc space.Infection occurred to the intervertebral disc space between l4 and l5 and the pedicle on the right side of l5.

• 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: 8924892
• Report Number: 1030489-2019-00938
• Device Sequence Number: 13965209
• Product Code: NKB
• UDI-Device Identifier: 00643169501072
• UDI-Public: 00643169501072
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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: 04/16/2023
• Device Catalogue Number: 54750016540
• Device Lot Number: H5179044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/23/2019
• 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: Other; Required Intervention