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

Catalog Number 7893040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 10/20/2017

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.Unknown screw (qty: 01) and set screw (qty: 01) were also used in the surgery (product id and lot number were not provided).Although it is unknown if the device 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 the patient underwent transforaminal lumbar interbody fusion (tlif) at l1-l4 due to back and radicular pain.Po st-op, although the patient has done well from a back pain and radicular pain standpoint, she has had hives (an allergic reaction) intermittently since her implantation.Patient does have a latex allergy, but was not knowingly exposed to latex during her surgery.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7298643
• MDR Text Key: 100999377
• Report Number: 1030489-2018-00280
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00613994168870
• UDI-Public: 00613994168870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2021
• Device Catalogue Number: 7893040
• Device Lot Number: 0532799W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2016
• 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