MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON LEGACY 5.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7480113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding an event happened during intra-op of the reported product.The pre-op diagnosis of patient was lumbar disc herniation with radiculopathy, lumbar spinal stenosis, lumbar osteoarthropathy.It was reported that, the patient underwent lumbar internal fixation surgery in other hospital in 2012, using other brand of internal fixation product at that time.The patient underwent revision surgery on (b)(6) 2022.Internal fixation was performed with medtronic spine legacy 5.5 system screws during the operation.During the operation, the tip of the nailing device was broken, and the broken part of the nailing device remained in the inner core of the screw, so that the screw could not be fixed with the rod.Immediately, the screw was removed, and new medtronic screw was replaced for fixation.The operation was completed without adverse consequences.The procedure or technique performed was removal of lumbar internal fixation device, lumbar laminectomy and decompression, nucleus pulposus exploration, internal fixation via pedicle system, intertransverse bone graft fusion.There was no patient symptoms or complications reported.There was no additional treatment or surgery performed as a result.There was a delay of less than 60 minutes reported as a result of this event.No further complications reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON LEGACY 5.5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14602263
• Report Number: 1030489-2022-00526
• Device Sequence Number: 14743621
• Product Code: LXH
• UDI-Device Identifier: 00721902861468
• UDI-Public: 00721902861468
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7480113
• Device Catalogue Number: 7480113
• Device Lot Number: PR15M005
• 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: 05/12/2022
• Initial Report FDA Received Date: 06/06/2022
• Date Device Manufactured: 03/12/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female