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

Catalog Number 1664017

Device Problem Metal Shedding Debris (1804)

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

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that patient with lumbar canal stenosis underwent oblique lumbar interbody fusion at l2-5 and then underwent posterior fusion.Intra-op surgeon kept inserting set screw at l2 right although it made strange noises.The surgeon stopped the procedure once because the set screw¿s fragment was found.The event occurred when pushing the rod which is not seated into the screw head.It was removed using forceps and the surgical field was cleaned as much as possible.After that, the surgeon made a space for sinking a rod holder to ventral side again and new set screw was inserted then the surgery was finished.No fragments of the set screw remained inside the patient.No patient complications were reported.

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: 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: 6137383
• MDR Text Key: 61192480
• Report Number: 1030489-2016-03310
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2023
• Device Catalogue Number: 1664017
• Device Lot Number: 0429362W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2015
• 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 Age: 75 YR
• Patient Weight: 49