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

Catalog Number 1555200500

Device Problem Migration (4003)

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

Event Date 11/28/2019

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

Event Description

Patient demographics: gender-male pre-operative diagnosis: procedure: levels implanted:4 it was reported that the patient underwent 3 level oblique lumbar interbody fusion (olif) with 1 level transforaminal lumbar interbody fusion (tlif) due to degenerative scoliosis.Post-op, rod was shifted out from mas screw even through the surgeon did final tightening for the non break off set screw.The patient underwent revision surgery.The surgeon did the revision because the bottom rod shifted out from the last mas screw which is at l5.He changed one new non break off set screw for l5.And from the xray, it showed that the bottom rod was out long enough from last screw.

Manufacturer Narrative

Radiographic image results: post-op x rays for multilateral spinal fusion l1-l5.Interbody grafts are present at l1-2, l2-3, l3-4, l4-5.Unable to assess fusion status.The lumbo-sacral transition 3 lordotic.One of the rods is out of the screw head at l5 and appears short for the construct.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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9522683
• MDR Text Key: 172803927
• Report Number: 1030489-2019-01490
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169272255
• UDI-Public: 00643169272255
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1555200500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: No
• 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