Catalog Number 04.614.508 |
Device Problems
Migration or Expulsion of Device (1395); Unintended Movement (3026)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation and was reportedly discarded by the reporting hospital.(b)(6).(b)(4).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.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 (b)(6) reported the following event: it was reported that a patient underwent revision surgery including hardware removal and irrigation and debridement (i&d) of a posterior cervical construct due to post-surgical screw back-out.The original posterior cervical decompression and stabilization procedure was performed on (b)(6) 2016, between levels c2-c6 using synthes synapse cervical system implants.The construct consisted of two (2) rods and ten (10) locking screws.On an unknown date it was discovered that five (5) of the ten (10) locking screws had backed out and the rods were exposed between the locking screws.Revision surgery was performed on (b)(6) 2016.During this surgery the five (5) complaint screws were removed intact and were replaced with five (5) new synthes titanium locking screws of the same part number.The surgeon used a torque limiting handle instrument for final tightening.There was no surgical time delay or additional medical intervention required.The surgery was successfully completed with no patient harm.This report is 2 of 5 for (b)(4).
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Manufacturer Narrative
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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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It was reported that the construct consisted of two (2) rods, ten (10) polyaxial screws, and ten (10) locking caps.On an unknown date it was discovered that five (5) of the ten (10) locking caps backed out and the rods were exposed between the locking caps.Concomitant medical products: synapse rods (part# unknown, lot# unknown, quantity# 2); polyaxial screws (part# unknown, lot# unknown, quantity# 10); locking caps (part# unknown, lot# - unknown, quantity# 5).
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Search Alerts/Recalls
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