WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.434 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
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Model Number SD800.434 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Additional narrative: 510k: this report is for an unk - peek implant/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on (b)(6) 2022, the psi group failed to make 3mm holes.There were no patient consequences.Procedure outcome is unknown.This complaint involves one (1) devices unk - peek implant.This is report 1 of 1 for complaint (b)(4).
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Event Description
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It was further reported that the psi was not able to be used.3mm holes were not made in the psi.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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