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

Catalog Number 6440530

Device Problems Metal Shedding Debris (1804); Device Operational Issue (2914)

Patient Problem Pain (1994)

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.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on an unknown date, post-op, patient presented to surgeon with pain.Bone scan completed and showed hot spots at l3 and s1.Surgeon decided to reoperate and replace the set screw in revision surgery.During removal surgeon noticed a large amount of metallosis on the left l3 level and loosing of the set screw.

Manufacturer Narrative

Product analysis: the set screw has a channel running through the equator of the set screw face.One side of the channel is thicker than that the other.There is a witness mark on the outer edge of the set screw.These two observations are consistent with the rod being over angulated in the bone screw head at the time of the set screw being installed.This could cause the rod not to set properly in the bone screw head.The root cause of the one set screw backing out is consistent with angle of the rod in respect to the saddle of the bone screw.This allowed the rod to move inside the bone screw head, removing material from the set screw.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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7618081
• MDR Text Key: 111615915
• Report Number: 1030489-2018-00865
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143375
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6440530
• Device Lot Number: 0513384W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• 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): Other; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 83