MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48644014
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Neck Pain (2433); Ptosis (2620)
Date of Event	09/10/2007
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Current location of the device is unknown.
Event or Problem Description
A patient reported that a revision surgery occurred sometime in 2010, possibly to address, ¿some loose or fractured screws,¿ (patient was unclear on the event).Follow-up information, including preoperative and intraoperative notes, does not indicate the presence of loose or fractured screws.The physician¿s notes (dated 10 september 2007) indicate the patient experienced headaches, a decrease of sensation on the left side along with, ¿moderate left side ptosis,¿ and, ¿left-sided horner¿s syndrome¿.The physician additionally noted, ¿right pupil 2.5 mm down to 2 mm with light," and, "left pupil 2 mm down to 1.5 mm with light.¿ the operative report (dated 01 september 2010) states that the patient was noted to have, ¿persistent cervical and occipital pain.¿ pre- operative imaging showed, ¿presence of pseudarthritis with lucency around her screws and a paucity of interbody support." this report captures the fourth of four reflex hybrid bone screws.Reports have been filed separately for associated devices.
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 performed as the device was not returned and the lot number was not provided.Per instructions for use: the surgeon must warn the patient of the surgical risks and made aware of possible adverse effects.The surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advice the patient that resultant forces can cause failure of the device.Patients who smoke have been shown to have an increased incidence of nonunions.Surgeons must advise of this fact and warned of the potential consequences.For diseased patients with degenerative disease, the progression of degenerative disease may be so advanced a the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopaedic devices may be considered only as a delaying technique or to provide temporary relief.Foreign body sensitivity.Where material sensitivity is suspected appropriate tests must be made prior to material implantation.No further investigation can be performed due to insufficient information provided.If more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.
Event or Problem Description
A patient reported that a revision surgery occurred sometime in 2010, possibly to address, ¿some loose or fractured screws,¿ (patient was unclear on the event).Follow-up information, including preoperative and intraoperative notes, does not indicate the presence of loose or fractured screws.The physician¿s notes (dated 10 september 2007) indicate the patient experienced headaches, a decrease of sensation on the left side along with, moderate left side ptosis,¿ and, ¿left-sided horner¿s syndrome.¿ the physician additionally noted, ¿right pupil 2.5 mm down to 2 mm with light," and, "left pupil 2 mm down to 1.5 mm with light.¿ the operative report (dated 01 september 2010) states that the patient was noted to have, ¿persistent cervical and occipital pain.¿ pre-operative imaging showed, ¿presence of pseudoarthrosis with lucency around her screws and a paucity of interbody support." this report captures the fourth of four reflex hybrid bone screws.Reports have been filed separately for associated devices.

• Brand Name: REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8952407
• Report Number: 0009617544-2019-00101
• Device Sequence Number: 2521073
• Product Code: KWQ
• UDI-Device Identifier: 04546540534682
• UDI-Public: 04546540534682
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 48644014
• Device Lot Number: 131553
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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: 38 YR