Model Number 55-PA-3526 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Patient weight, ethnicity, and race information - unknown.Occupation - other; sales representative.Device evaluated by mfr - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
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Event Description
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It was reported that a procedure was performed by on (b)(6) , 2022, utilizing the reform poct pedicle screw system.During attempted insertion of one ø3.5 x 26mm polyaxial screw (55-pa-3526) the screw broke.Due to the location of the break, it was not possible to remove, so the distal portion of the broken screw was left in the patient's pedicle.Five (5) additional screws, 2 rods and 5 locking caps were successfully implanted with no further issue.There was no patient harm or meaningful delay to the procedure resulting from the broken screw.
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Event Description
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It was reported that a procedure was performed by on (b)(6) 2022, utilizing the reform poct pedicle screw system.During attempted insertion of one ø3.5 x 26mm polyaxial screw (55-pa-3526) the screw broke.Due to the location of the break, it was not possible to remove, so the distal portion of the broken screw was left in the patient's pedicle.Five (5) additional screws, 2 rods and 5 locking caps were successfully implanted with no further issue.There was no patient harm or meaningful delay to the procedure resulting from the broken screw.
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Manufacturer Narrative
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H3 device evaluation - the screw is fractured approximately 11mm below the bottom of the tulip.A review of cad models indicates that approximately 15.5mm of screw length remains in the patient.The break is at the root of the thread and is in a plane that is nearly perpendicular to the screw's longitudinal axis.This failure is what would be expected in a torsional overload condition.It was noted that the cavity had been tapped but based upon the failure mode it appears that excess torque was applied in an effort to seat the screw.The reason for the need to apply high torque after tapping is not clear so the cause remains unknown.Review of device history records found (b)(4) pieces of lot 39562ps released for distribution on 2/10/2022 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are being recommended at this time.
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Search Alerts/Recalls
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