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 Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient previously implanted with a screw, set screws, and rod in an l1 to iliac + plif of l5/s for lumbar degenerative scoliosis.It was reported that this is a repeat surgery because of the pulling off of the set screws.During the postoperative observation, both sides of the set screws came off.There was no product malfunction with the screw and rod.No specific cause has been reported against the unknown screw.Clydesdale ptc was used in the initial surgery which was an l1 to l5/4 intervertebral olif performed for the posterior side (surgery #2).Surgery #1 was performed for the anterior side on (b)(6) 2022 at l1~l5.These two surgeries were the initial surgery.The doctor had planned to divide the initial surgery two times and these were performed as scheduled and succeeded.Pulling off of the set screws was discovered during the post-operative hospitalization follow-up of surgery #2, so the patient's hospitalization period was extended for the current operation.Additional surgery was performed where the iliac screws were replaced for fixation and the entire structure was re-tightened and replaced.There were no symptoms or complications as a result of this event.The date of implant for the first 4 products is (b)(6) 2022 and date of explant is (b)(6) 2022.The date of implant for the unknown screw is (b)(6) 2022 and remains implanted.No further complications were reported/ anticipated.
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.

• 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: 14238786
• Report Number: 1030489-2022-00419
• Device Sequence Number: 4338769
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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: 04/05/2022
• Initial Report FDA Received Date: 04/28/2022
• 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; Hospitalization
• Patient Sex: Female