MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	1555200500
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not 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
It was reported that on (b)(6) 2019, the patient underwent a fixation surgery at t10-pelvis using screws, set screws and rods.Post-op, on (b)(6) 2019, patient fell, due to which the rods slipped out of the screws and the set screws popped out.The patient also had some fractures in the sacrum region from the fall.It was believed that the flexion force from the fall caused the rods to slip and set screws to pop.A revision surgery was performed on (b)(6) 2019, in which the screws and the set screws were replaced with new ones.The rods were reused and were left implanted inside the patient.Current condition of the patient is good and is post one week with a successful revision.
Additional Manufacturer Narrative
X-ray review results: post-op and intra-op revision x-rays for t2-iliac fusion were provided.By report, patient fell and on x-rays, the rods are out of the iliac screw heads necessitating revision.The rods at the lumbosacral junction have a lordotic contour and are somewhat short to the screw heads.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8792908
• Report Number: 1030489-2019-00772
• Device Sequence Number: 11257075
• Product Code: KWP
• UDI-Device Identifier: 00643169272255
• UDI-Public: 00643169272255
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2019

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: 06/17/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/17/2019
• 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
• Patient Age: 48 YR