WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA; FILLER, BONE VOID, CALCIUM COMPOUND
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Pma/510k: this report is for an unknown biomaterial - preformed: chronos: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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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This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing spine, cmf and trauma-related procedures.¿ failed spine, cmf and trauma-related procedures has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: ¿ 97 patients had subsequent surgery within 0-3 months after the index surgery.13 patients had union complication such as pseudarthrosis (spine), nonunion (cmf), nonunion and malunion (trauma) within 0-3 months.283 patients had subsequent surgery within 0-12 months after the index surgery.53 patients had union complication such as pseudarthrosis (spine), nonunion (cmf), nonunion and malunion (trauma) within 0-12 months.¿ this is for depuy synthes chronos bone void filler.¿ this report is for one (1) unk - biomaterial - preformed: chronos: trauma.This is report 3 of 4 for (b)(4).
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Search Alerts/Recalls
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