Catalog Number A1059 |
Device Problem
Mechanical Problem (1384)
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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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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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This is 2 of 2 reports linked to mfg report number 3004608878-2021-00125.A facility reported that the locking knob on the mayfield modified skull clamp (a1059) was not working properly.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
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Manufacturer Narrative
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Mayfield modified skull clamp (a1059) was returned for evaluation.Unit received with the lock having both rotational and lateral movement and a residue buildup was present.Unit needs new components added to replace worn internal parts.This unit is beyond integra¿s 7 years recommended life cycle (manufactured in 2004).The reported complaint was confirmed via inspection of the unit.
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Search Alerts/Recalls
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