Product complaint # (b)(4).This report is for an unk - screw/rod construct/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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This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 74 patients (28 males,46 females) for viper / expedium pedicle screws with vertecem+ against all other surgical cases recorded within the spine tango registry between 06 february 2013 and 29 august 2018.Final registry report outcome description: general complications-intraoperative: 1 anaesthesiological, 1 pulmonary.Surgical complications- intraoperative adverse events: 3 dural lesion.General complications- postoperative surgical before discharge: 4 cardiovascular, 2 pulmonary, 1 cerebral, 3 kidney / urinary, 1 liver / gi, 1 thromboembolism, 2 other, 2 not documented.1 death.Surgical complications- postoperative surgical before discharge: 1 other hematoma, 1 radiculopathy, 2 motor dysfunction, 2 sensory dysfunction, 1 bowel / bladder dysfunction, 1 wound infection superficial, 10 wound infection deep, implant failure, 2 other, 2 not documented.Reoperations : 4 number of reoperations at any level: 2 adjacent segment pathology, 2 failure to reach therapeutic goals, 1 hardware removal, 1 implant failure, 1 instability, 1 neurocompression, 1 sagittal imbalance, 1 unknown, 1 number of reoperations at the same level, 1 unknown.This is for unknown depuy spine viper / expedium pedicle screws.A copy of the clinical evaluation form is being submitted with this regulatory report.This report is for one (1) unk - screw/rod construct.This is report 3 of 4 for complaint (b)(4).
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