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	55750017540
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/21/2020
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 presented with lumbar canal stenosis at l3-s1; and underwent percutaneous pedicle screw fixation and posterior lumbar interbody fusion at l3-l5, and transforaminal lumbar interbody fusion at l5-s1.About half a year, post-op, partial bone union failure occurred at l3-l4 and l4-l5; and general loosening of the pedicle screw occurred.It was judged that this event was not because of the alleged product but due to the characteristics of the disease (involuntary movements) and the effects of osteoporosis.Bone union was achieved at l5-s1.The patient also experienced lumbar backache.A revision surgery was scheduled to be performed on (b)(6) 2020; but it is unknown if this surgery has been performed or not.Pedicle screw replacement was planned during this surgery.

• 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: 10079700
• Report Number: 1030489-2020-00539
• Device Sequence Number: 3924047
• Product Code: NKB
• UDI-Device Identifier: 00643169783904
• UDI-Public: 00643169783904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2020

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 Catalogue Number: 55750017540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/21/2020
• 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: 56 YR