MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SPINAL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	75700450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
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
Information was received from a healthcare provider (hcp) via a medtronic representative regarding a patient implanted with a screw using a guidewire in a th12-s2ai posterior fixation (pps) for an l3 vertebral fracture.It was reported that during the procedure, the guidewire was used to insert the hollow screw and became difficult to remove.The screw was pulled back and the guidewire was removed.Afterwards, it was reinserted in a deeper region.No signs of damage were observed in the intraoperative images.The guidewire was broken.The guidewire used to insert the hollow screw remained inside of the ilium.The remaining guidewire was confirmed by the physician on the postoperative x-ray.After confirming with the physician, he determined that there were no problems.A repeat surgery is currently not planned.There is a plan to continue to follow-up on whether there are any problems after the surgery.The event was associated with the patient.There were no patient symptoms or complications as a result of this event.This was not a repeat surgery, there was no delay in the overall procedure time, no hospitalization or prolongation of hospitalization, and no treatment or additional surgery performed as a result of this event.The patient's medical history included hypertension, right inguinal hernia, lumbar spinal canal stenosis, ureteral calculi, prostate cancer, vater's papillary cancer, renal failure, cerebral infarction, pneumonia.No further complications were reported/ anticipated.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• 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: 13730644
• Report Number: 1030489-2022-00241
• Device Sequence Number: 5969291
• Product Code: LXH
• UDI-Device Identifier: 00643169542907
• UDI-Public: 00643169542907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2022

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: 75700450
• Device Catalogue Number: 75700450
• Device Lot Number: KH18G004
• 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: 02/18/2022
• Initial Report FDA Received Date: 03/11/2022
• Date Device Manufactured: 10/21/2020
• 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: 73 YR
• Patient Sex: Male