MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 5432031

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2016

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.

Event Description

Pre-op diagnosis: ossification of posterior longitudinal ligament (opll) and ossification of the yellow ligament (oyl) procedure: posterior thoracic decompression fusion levels of implant: th1-th12 it was reported that during surgery, a set screw could not be broken off.There was no space between the rod and the crosslink and it was closed so that the set screw could get in.The surgeon placed the crosslink and broke off a set screw on one side.When the surgeon tried to break off a set screw on the other side, torque could not be applied to the set screw and the set screw got into the thread of screw.The surgeon removed the screw using removal screw driver and tried it again with a new screw but same event occurred.The surgeon attempted to remove the setscrew that was successfully broken off first using removal screw driver but it was difficult to remove because the driver stripped.The surgeon judged that it did not need to be removed because it was tightly tightened, and the screw on the other side remained in the patient¿s body without breaking off.No patient complications were reported as a result of this surgery.

Manufacturer Narrative

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

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6266011
• MDR Text Key: 65351798
• Report Number: 1030489-2017-00130
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2022
• Device Catalogue Number: 5432031
• Device Lot Number: 0344915W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2014
• 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 Weight: 100