DEPUY SPINE INC 5.5 EXP VERSE CAN SCR 7.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 199725740S |
Device Problem
Device Slipped (1584)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2021 |
Event Type
malfunction
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a revision surgery.During the surgery, l6 screws found loose, and the cage had not been secured to the lesion and come off the lesion.The surgery is completed successfully.No further information is available.Concomitant device reported.Unknown rod (part# unknown, lot# unknown, qty unknown); unknown set screw (part# unknown, lot# unknown, qty unknown).This complaint involves three (3) devices.This report is for (1) 5.5 exp verse can scr 7.0x40.This report is 1 of 2 for (b)(4).Related product complaint: (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).Additional narrative: additional product code: kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: h3, h4, h6: part 199725740s, lot 265093: the product was released on: december 16, 2019.A manufacturing record evaluation was performed for the finished device and no non-conformances/manufacturing irregularities were identified during the manufacturing process.H3, h6: a photo investigation was completed: visual analysis of the provided images revealed that there was no damage or defects.A dimensional inspection was not performed as the device was not returned.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the device was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
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