Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown spine screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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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Device report from synthes reports an event in (b)(6) as follows: it was reported during a three (3) month post surgery check up it was noted that the cervical spine locking plate (cslp) iii quicklock screws came loose at the caudal part of the cslp iii plate which was used to treat a three stage spinal fusion.This was determined by x-ray.No revision surgery is currently planned and the devices remain implanted.Concomitant device reported: unknown cslp iii plate (part#: unknown, lot#: unknown, quantity 1).This is report 2 of 6 for (b)(4).This report is for an unknown spine screw.
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Event Description
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Additional event information this complaint involves seven (7) devices.
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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.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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Manufacturer Narrative
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Product complaint#: (b)(4).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.Revision was not performed.Situs healed according to surgeon and revision was not necessary.Therefore, no device has been explanted and therefore no device is available for return.If you do not know the lot number of used devices, non-sterile product was used which has no lot trackability post implantation.Customer regularly buys lcp screws of all sizes.Many screws of many sizes which have been bought over a period of six (6) months are to be considered for implantation.It is not possible to single out an item lot combination which has been sold to the customer.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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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.The complaint condition could not be confirmed because the x-rays pictures are in a poor quality.Product was not returned.Based on the information available, it has been determined that no corrective and 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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Concomitant device reported: unknown cslp iii plate (part# unknown, lot# unknown, quantity 1); unknown cslp iii quicklock screws (part# unknown, lot# unknown, quantity 5).
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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.H11: corrected data: b5, awareness date reported on follow up 1 report as (b)(6) 2020 but should have been (b)(6) 2020.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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