OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM LCP RECONSTRUCTION PLATE 6 HOLES/84MM STERILE; APPLIANCE,FIXATION,NAIL
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Catalog Number 245.061S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is company sales consultant.(b)(4).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 that the patient underwent a revision surgery on an unknown date due to a failure of 3.5mm locking compression plate (lcp) reconstruction plate 6 holes/84mm.No other information provided.This report is for one (1) 3.5mm locking compression plate (lcp) reconstruction plate 6 holes/84mm.This is report 1 of 1 for complaint (b)(4).
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Event Description
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Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).
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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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Search Alerts/Recalls
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