Catalog Number A1059 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number 3004608878-2020-00459.
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Event Description
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This 1 of 2 reports.A customer reported that the locking knob of the a1059 mayfield modified skull clamp was broken.There was no known patient injury or surgery delay.
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Manufacturer Narrative
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(b)(4).The device was returned for evaluation.No dhr review was possible as the provided serial number (b)(6).Does not appear to be a valid integra identification number.No other lot or serial number was provided during the complaint investigation.The reported complaint was not confirmed via inspection of the unit.While the swivel lock had rotational and lateral movement while locked, it did stay locked.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.The device is seven (7) years old (manufactured in 2008).
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Event Description
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N/a.
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Search Alerts/Recalls
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