MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CD HORIZON LEGACY SPINAL SYSTEM

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Weakness (2145)

Event Type  Injury  

Manufacturer Narrative

Adverse event: others: fracture, delayed-union, weakness, bursitis, pain.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

A multi-center retrospective observational study was conducted to obtain post-market clinical data for medtronic spine implantable devices.This data was queried and grouped based on the specific medtronic system used in the surgical procedure and analyzed to establish real-world evidence (rwe) for the performance and safety of the device in question when used as part of standard clinical practice.This data collection is one part of ongoing post-market clinical surveillance activities that are intended to confirm and monitor the safety and performance of the device.This report summarizes the clinical data obtained by medtronic as part of this retrospective observational study.Data obtained as part of this study was provided to in a de-identified format and thereby provides no patient or product specific identifiers.As per this clinical evaluation report, it was reported that the patient diagnosed with stenosis, spondylolisthesis, and disc degeneration, underwent a four-level, lumbar, posterior, spine fusion procedure.This patient was implanted with a spinal construct that consisted of the endcap, used as an interbody spacer, and the alleged system for posterior spinal fixation.At 6 months post-operative, there was radiographic evidence of evolving bone consolidation at the interbody fusion levels of l1-l2 and l4-l5.However, at 14-months post-operative, there was evidence of delayed union at l4-l5 with an l5 pedicle fracture and pedicle screw break-out, requiring a revision surgery at 15 months post-operative.This patient experienced developed trochanteric bursitis and experienced continued back pain and lower extremity weakness.It is unknown if these symptoms were alleviated following the revision surgery.

• Brand Name: CD HORIZON LEGACY SPINAL SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 10187373
• MDR Text Key: 201029017
• Report Number: 1030489-2020-00702
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other