MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SOLERA® SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 54850016545

Device Problem Mechanics Altered (2984)

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

Event Date 02/17/2022

Event Type  malfunction  

Event Description

Information was received from distributor via healthcare provider regarding a patient having l3-l4 mis-tlif surgery due to l3-4 hivd.It was reported that, the patient underwent the during the surgery, the surgeon confirmed the counter torque is fully seated.The surgeon inserted the set screw driver with attached break-off handle.The surgeon can spin the break-off handle, but it failed to listen the sound 'pia' and were broken off successfully.The surgeon replaced with the another set screw, it was in the same situation.Finally, the surgeon unscrewed the screw and replaced with the new screw but the set screw is the same, it succeeded to be broken off and complete the surgery.There were no symptoms reported as a result of this event.No further complications reported regarding the event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® SOLERA® SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13754821
• MDR Text Key: 288814419
• Report Number: 1030489-2022-00246
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169491564
• UDI-Public: 00643169491564
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K143375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54850016545
• Device Catalogue Number: 54850016545
• Device Lot Number: H5688700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2022
• Date Device Manufactured: 06/09/2021
• 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 Sex: Male