Catalog Number A1059 |
Device Problems
Mechanical Problem (1384); Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 mayfield modified skull clamp (a1059) needs calibration and the torque tension does not seem to secure appropriately.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.
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Manufacturer Narrative
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Device history record: the dhr shows no abnormalities related to the reported failure.Mayfield modified skull clamp (a1059) was returned for evaluation.The reported complaint was confirmed from the evaluation.The set screw in the swivel base was tight and the unit needs to be machined to have heli-coils added to large starburst threads.The evaluation showed that the lock having both rotational and lateral movement and have a residue buildup.The unit needs repair, and replacement of worn/damaged parts.General maintenance and cleaning required.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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Event Description
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N/a.
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Search Alerts/Recalls
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