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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Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.Linked to mfg report numbers: 3004608878-2020-00629 and 3004608878-2020-00628.
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Event Description
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This is 2 of 3 reports.It was 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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Unique device identification(udi): (b)(4).Mayfield skull clamp was returned for evaluation.Device history record (dhr) - the dhr shows no abnormalities related to the reported failure.The reported complaint was confirmed from the evaluation of the returned product.The lock has rotational and lateral movement and a residue buildup is present.Unit need new components added to replace worn internal parts.The observed condition is likely caused by wear and tear.The definite root cause cannot be reliably determined.
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Search Alerts/Recalls
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