Catalog Number A1059 |
Device Problem
Peeled/Delaminated (1454)
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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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A facility reported that the starburst on the mayfield modified skull clamp (a1059) was stripped.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
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Event Description
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N/a.
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Manufacturer Narrative
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Mayfield modified skull clamp (a1059) was returned for evaluation.The reported complaint was confirmed via inspection of the unit.Unit received with the lock having both rotational and lateral movement and a residue buildup was present.Upon disassembly repair notes the index knob and the lock will need new components added to replace worn internal parts.Unit needs to be machined to have heli-coils added to large starburst threads.The set screw in the swivel base was tight.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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Search Alerts/Recalls
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