MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ORION; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	9790035
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Hyporesponsive to stimuli (2683)
Date of Event	03/26/2020
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
Pre op diagnosis: spinal cord injury procedure performed: anterior 4 cervical subtotal vertebral body subtotal resection, cervical 3-4, 4-5 discectomy, spinal canal and spinal nerve decompression, bone graft fusion and internal fixation post op, steel plate migrated.The patient developed new neurological symptoms, and the patient's lower limb decreased sensation.As a result of this revision surgery was performed.In revision surgery they removed the original steel plate, re-expanded the decompression range, and replaced with a longer steel plate.

• Brand Name: ORION
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 9980295
• Report Number: 1030489-2020-00461
• Device Sequence Number: 11911584
• Product Code: KWQ
• UDI-Device Identifier: 00721902988998
• UDI-Public: 00721902988998
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2020

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: 9790035
• Device Lot Number: 0706162W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/21/2020
• 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: Other; Required Intervention
• Patient Age: 48 YR