MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - MONO/POLY SCREWS: SYNAPSE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).This report is for an unknown mono/polyaxial screws: synapse/unknown lot.Part and lot number are unknown.Without the specific part number the device history records review could not be completed; and the udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.Product was not returned therefore no further investigation possible.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available (information or/and material), the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: burley hek, et al.(2020), tulip-screw head disjunction from posterior c2 fracture fixation instrumentation, hindawi case reports in orthopedics, volume 2020, article id 5824383, 5 pages, (usa) this report presents an unusual case of instrumentation failure after posterior fixation of a c2 fracture and reviews currently available treatment alternatives.A (b)(6) female presented with acute alcohol intoxication and acute neck pain following a fall from a ladder.Computed tomography (ct) imaging of her cervical spine demonstrated bilateral c2 pars fractures.There was no listhesis of the body of c2, but the posterior elements were displaced posteroinferiorly and determined to be unstable.She underwent an emergent c2 open-reduction internal fixation (orif) at the outside facility.The procedure was performed from a posterior approach via standard midline incision at c1-4 with the patient prone.Unknown synthes synapse system polyaxial 3.5mm pedicle screws were implanted bilaterally.There were no known complications and the patient was discharged home after the operation.8 months after the index operation, she presented to our clinic for reevaluation, complaining of posterior neck pain that had not improved since surgery.She was experiencing frequent headaches, new onset vertigo, and limited range of motion unresponsive to conservative management.A ct scan of the cervical spine revealed a healed c2 fracture with intact instrumentation.The patient was referred to further physical therapy with massage and scheduled for a repeat ct scan in 1 year.She instead returned at 9 months with concerns of a firm, mobile bump at the posterior aspect of her neck accompanied by shooting pain radiating to the head.X-rays performed at this visit demonstrated stable c2 lateral mass screws with no other interval changes, and she continued conservative management at this time.At her scheduled 2-year follow up, she continued to complain of a posterior neck mass and pain.A ct scan revealed that bilateral tulip caps had detached from the pedicle screw heads at c2.The patient¿s original fracture had healed, without any evidence of pseudarthrosis.Due to her discomfort, surgical removal of the instrumentation was recommended the patient underwent an elective instrumentation removal.The tulip heads were visibly disengaged from their respective screws and extensive metallosis was observed in the surrounding tissue.Upon inspection of the implant, there was erosion of the coupling portion of the tulip head (figure 3).Once the tulips were removed, the pedicle screws were removed at c2 bilaterally and the incision was closed.Postoperative ct scan demonstrated removal of instrumentation with complete healing of the original c2 fracture.The postoperative course was uncomplicated and she was discharged in stable condition.This report is for the unknown synthes synapse system polyaxial 3.5mm pedicle screws this report is 1 of 1 for (b)(4).

• Brand Name: UNK - MONO/POLY SCREWS: SYNAPSE
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA
• MDR Report Key: 11819423
• MDR Text Key: 262153405
• Report Number: 2939274-2021-02350
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR