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

Model Number	6541101
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
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 implanted with screws in a posterior pedicle screw fixation with cemented screws at l4/5 for back pain, radicular symptoms.It was reported that the locking cap of the fns screw was torqued off and the broken off part was removed.However, the locking cap has come loose and is floating in muscle above the construct.The locking cap torqued off as normal.The surgeon followed the steps as normal and indicated.The fns screw's locking cap is the suspected issue but the set screw was reported as well as the threads may be damaged in that too.There were no patient symptoms or complications as a result of this event.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
H6: the device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with screws in a posterior pedicle screw fixation with cemented screws at l4/5 for back pain, radicular symptoms.It was reported that the locking cap of the fns screw was torqued off and the broken off part was removed.However, the locking cap has come loose and is floating in muscle above the construct.The locking cap torqued off as normal.The surgeon followed the steps as normal and indicated.The fns screw's locking cap is the suspected issue but the set screw was reported as well as the threads may be damaged in that too.There were no patient symptoms or complications as a result of this event.Revision took place on 19-may-24.The cap did not torque off correctly as there was cement in the tulip from when they augmented the screw.The surgeon removed the cement and fitted a new locking cap into the existing screw tulip.Floating locking cap was disposed of.The set screw was removed from patient and discarded and only the pedicle screw remains in the patient.The patient's medical history included atrial fibrillation- paroxysmal.Patient was prescribed metoprolol to take when needed, but the last episode of palpitations was approximately 2 years ago.The patient also has a history of hypolipidemia.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
A2: updated patient age.A4: updated patient weight.B1,h1: since revision surgery occurred, this event is serious injury reportable.B2: updated outcome attributed to adverse event.B5: updated event details.D6b: updated explant date as set screw was explanted h6: updated eval.Code method as set screw was discarded post explantation updated annex f code due to revision surgery on (b)(6) 2024.Radiographic image review of lateral x-ray l4-5 fusion with cement augmentation states that one of the setscrews is out of the screw tulip into the soft tissues as described.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CD HORIZON® SOLERA® VOYAGER¿ 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: 19246561
• Report Number: 1030489-2024-00394
• Device Sequence Number: 6598613
• Product Code: NKB
• UDI-Device Identifier: 00763000211196
• UDI-Public: 00763000211196
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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: 6541101
• Device Catalogue Number: 6541101
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/23/2024
• 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: 60 YR
• Patient Sex: Unknown
• Patient Weight: 54 KG