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Device Problem
Packaging Problem (3007)
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Patient Problem
No Code Available (3191)
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Event Date 04/25/2017 |
Event Type
Injury
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Manufacturer Narrative
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Upon receipt of the additional information on july 19, 2017 it was detected that previously reported device unknown locking cap (reported under complaint (b)(4), (b)(4), alert date: apr 28, 2017) is no longer associated with complaint (b)(4) and needs its own complaint.Therefore a new complaint (b)(4) has been opened to address the issue of the locking cap.Additional device product codes: mni, mnh, kwp, kwq this report is for one (1) unknown end cap.Part and lot numbers are unknown.Without a specific part and lot numbers, the udi is not available.Device is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6) (510k): unknown, as specific part number for end cap is not provided.Patient code is used as the package was missing an end cap which led to the surgeon putting in the screw without an end cap.The patient eventually needed a revision surgery prompted by a loosening screw.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the patient was a victim of spinal cord injury by firearm projectile in 2016, with l4 fracture requiring l2-l3-l5-s1 arthrodesis.During the initial surgery insufficiency of blockers in the sent box was verified (only 7, surgery with placement of 8 screws, without contamination of blockers during the surgery).As the patient was already anesthetized, the surgeon decided to leave the l5 screw to the left without a blocker.Post-operatively approx.One year the patient needed a revision surgery severe low back pain and severe deformity in the operated area.This complaint addresses the intraoperative issue of blocker (locking cap) missing during initial surgery.The postoperative issues of severe back pain, issues of s1 level screw loosening and disconnection of right l5 level screw has been reported under the linked complaint (b)(4).This report is for one (1) unknown end cap.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Corrected data: upon receipt of the additional information on july 19, 2017 it was detected that previously reported device unknown locking cap (reported under complaint (b)(4), alert date: apr 27, 2017) is no longer associated with complaint (b)(4) and needs its own complaint.Therefore a new complaint (b)(4) has been opened to address the issue of the locking cap.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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Event Description
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Concomitant reported parts: 2x click'x spondylolisth.Screw (part 499.552 lot 8767839 and 8784689), 2x click'x spondylolisth.Screw (part 499.551 lot 8593112 and 7942649), 2x rod (part 498.154 lot 8708913 and 9023296), 7x click'x locking cap (part 498.570 1x lot 8895051 and 6x lot 9569162).
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Search Alerts/Recalls
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