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

Catalog Number	811-323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	09/11/2017
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.
Event or Problem Description
Pre-operative diagnosis: spinal stenosis it was reported that the patient underwent laminectomy with instrumented fusion at l5-s1 in (b)(6) 2002, screws and crosslink were implanted in this initial surgery.Post-op, the patient experienced adjacent level disease at l4-5.Also, fusion had occurred at l5-s1, so the previous hardware was removed and new pedicle screws and rods were placed on (b)(6) 2017.During removal surgery, the doctor noticed a pseudomeningocele (abnormal collection of cerebrospinal fluid - csf) underneath the crosslink.The dura was repaired and new hardware was placed at l4-l5.

• 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: 6933705
• Report Number: 1030489-2017-02165
• Device Sequence Number: 11058119
• Product Code: KWP
• UDI-Device Identifier: 00673978042756
• UDI-Public: 00673978042756
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K981676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 811-323
• Device Lot Number: 64912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/10/2017
• 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: Other
• Patient Age: 59 YR