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

Catalog Number	1555200500
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 9522683
• Report Number: 1030489-2019-01490
• Device Sequence Number: 19525368
• Product Code: NKB
• UDI-Device Identifier: 00643169272255
• UDI-Public: 00643169272255
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1555200500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention