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

Model Number 1556300500

Device Problem Crack (1135)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/11/2022

Event Type  malfunction  

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient having preoperative diagnosis for reinforcement surgery due to bilateral rod breakage.Initial surgery or the procedure taken was t9/s2 fixation with the degenerative kyphoscoliosis it was reported that due to broken rods on both sides, reinforcement was performed using a connector from another company.Although it is not a broken piece, the broken rods on both sides are left as is and reinforcement is performed with connectors.Initial surgery was performed on (b)(6)2020.There were no symptoms reported.There were no further complications reported regarding the event.The broken rods are still in use as they are.They were broken but were not separated into plural pieces/fragments.So, no fragments are remaining inside the patient body.The report indicates 'broken' but the actual condition of the rods seems to be closer to 'having cracks'.There is no plan to remove them.

Manufacturer Narrative

510k number: the device p/n 1556300500 is similar to the device manufactured in us p/n 1556000500.Hence, mentioned 510k license number k111942 is of p/n 1556000500.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.

• Brand Name: CD HORIZON® 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: 14300221
• MDR Text Key: 291364352
• Report Number: 1030489-2022-00437
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10.
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1556300500
• Device Catalogue Number: 1556300500
• Device Lot Number: 0691218W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Date Device Manufactured: 12/20/2018
• 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
• Patient Age: 76 YR
• Patient Sex: Female