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Model Number PC2-200004 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Event Description
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On 12 dec 2023, seaspine was made aware of four post-op infections that had occurred over a three-month period associated with surgical cases utilizing the northstar posterior cervical fusion system.This report is for 3 of 4 patients.No further information was provided regarding the patient's condition.
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Manufacturer Narrative
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The customer returned two pc2-200004 rod cutters (udi: (b)(4), lots: al641538b & al639162b) for inspection.Per the reporter, the surgeon suspected that contamination was present in the cutting chamber.Currently, there is no evidence to support this suspicion.Investigation is ongoing.Possible adverse events: serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, including hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism; or death.
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Event Description
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On 12 dec 2023, seaspine was made aware of four post-op infections that had occurred over a three-month period associated with surgical cases utilizing the northstar posterior cervical fusion system.This report is for 3 of 4 patients.Two (b)(4) rod cutters (udi: (b)(4), lots: al641538b & al639162b) were returned for investigation.This report is for lot al641538b.
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Manufacturer Narrative
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Two (b)(4) rod cutters (udi: (b)(4), lots: al641538b & al639162b) were returned for investigation.Per the reporter, the surgeon suspected that contamination was present in the cutting chamber.Seaspine inspection did not observe any visible contaminants.These units had been sterilized post-procedure at the hospital and sent non-sterile via the standard complaint return process.Because of this, standard bioburden testing was infeasible.External labs were unable to test for sterility outside of a controlled contamination cleaning validation.No further evaluation can be performed.Follow-up discussions with the reporter confirm that all patients received wound washout and recovered, to her knowledge.She stated they added an additional disinfection step to their cleaning process, and the surgeon believes it could have just been patient selection.A review of complaint data over the last six years confirms these are the first reports of infection related to seaspine instrumentation.At this time there is no evidence to suggest that the instruments contributed to the reported events.Possible adverse events: serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, including hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism; or death.
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Search Alerts/Recalls
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