MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 2 LEVEL ACP SIZE 32MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48651232
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Paralysis (1997); Pneumonia (2011); Perforation of Esophagus (2399)
Date of Event	07/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device are currently unknown.
Event or Problem Description
A representative for the patient reported that a reflex-hybrid 2 level acp plate migrated approximately six years after implantation causing an esophageal perforation which lead to an infection, abscess, and pneumonia.The patient reportedly underwent a revision surgery, during which time they experienced paralysis of the vocal cord and left side of the neck.It is additionally reported that the infection lead to osteomyelitis for which the patient underwent additional surgeries.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.A device and complaint history review could not be performed as a valid lot number was not provided and could not be obtained.The reflex hybrid surgical technique indicates: foreign body sensitivity: where material sensitivity is suspected appropriate tests must be made prior to material implantation.Contraindication: rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis.Osteoporosis or osteopenia are relative contraindications, since this condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.These systems are indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients.Stryker spine devices are designed for treatment of fracture or stabilization of a surgical site during the normal bone consolidation process.After this period, the presence of the device is no longer strictly required and its removal can be planned.Patients who smoke have been shown to have an increased incidence of nonunion.Initial surgery was performed on or about (b)(6) 2011.It is unknown if the patient fused.Patient bone quality and bone pathology is unknown.Device documentation states that implants may migrate due to fatigue of construct prior to or beyond the expected life.The most likely root cause is fatigue on construct beyond expected life.
Event or Problem Description
A representative for the patient reported that a reflex-hybrid 2 level acp plate migrated approximately six years after implantation causing an esophageal perforation which lead to an infection, abscess, and pneumonia.The patient reportedly underwent a revision surgery, during which time they experienced paralysis of the vocal cord and left side of the neck.It is additionally reported that the infection lead to osteomyelitis for which the patient underwent additional surgeries.

• Brand Name: REFLEX-HYBRID 2 LEVEL ACP SIZE 32MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9749823
• Report Number: 0009617544-2020-00029
• Device Sequence Number: 727567
• Product Code: KWQ
• UDI-Device Identifier: 04546540534811
• UDI-Public: 04546540534811
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K063430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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 Model Number: 48651232
• Device Catalogue Number: 48651232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 06/15/2020
• 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