MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SOLERA SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	6534530
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient who underwent revision surgery for 2a2b fixation due to upper screw loosened and backed out.It was reported that the screw backed out that caused pain.Revision surgery was scheduled for removal of screw and no further complications or symptoms were reported.Additional information was received via manufacturer representative that the revision surgery was performed and product was explanted on (b)(6) 2022.The operation on (b)(6) 2022 was for l2 rupture fracture and l1/2 decompression.There was an infection in the decompressed area and was subsided by washing and antibiotics.The loosening is due to the patient's bone fragility, so the doctor decided to remove all implanted products.Because, even if fixing and extending are performed, it will become loose again, or the risk of leading up to adjacent vertebral body fracture will become higher.
Additional Manufacturer Narrative
H5736140 or h5736143.It is unknown which lot# of the product has been backed out.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.

• Brand Name: CD HORIZON® SOLERA SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14422920
• Report Number: 1030489-2022-00474
• Device Sequence Number: 20417960
• Product Code: NKB
• UDI-Device Identifier: 20643169885831
• UDI-Public: 20643169885831
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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 Model Number: 6534530
• Device Catalogue Number: 6534530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 65 KG