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

Model Number 75700450

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 289087464
• Report Number: 1030489-2022-00241
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00643169542907
• UDI-Public: 00643169542907
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/18/2022
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male