MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SOLERA SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 641000035

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  Injury  

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 professional(hcp) via a manufacturer representative regarding a spinal devices used in an unknown spinal therapy.It was reported that hardware failure.There were no patient symptoms associated with this event and no further complications were reported/anticipated.Additional information was received from the manufacturer representative that the rod came out of the tulips even though the set screws were locked in place.Procedure was done on (b)(6) 2022.Levels l5-s1.Everything was fine post case op on images.Months later the rods slipped out of the tulips.Doctor said that the patient was compliant.Patient was fused.Patient wanted to keep their hardware implants that were removed.Additional information was received from the manufacturer representative that the set screws were locked in place, the surgeon removed the rod first then the set screws.The set screws were hard to get out as they were final tightened.There was no malfunction/ allegation reported against screws and set screws.

• Brand Name: CD HORIZON SOLERA SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 15795900
• MDR Text Key: 303627833
• Report Number: 1030489-2022-01038
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 641000035
• Device Catalogue Number: 641000035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention