510 k: this report is for an unk - biomaterial - preformed: chronos: spine/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 jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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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Device report from synthes reports an event in (b)(6) as follows: 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 292 patients (148 males, 145 females) for zero-p implants against all other surgical cases recorded within the spine tango registry between (b)(6) 2012 and (b)(6) 2020.Final registry report outcome description: general complications: intraoperative 1 anesthesiologic.General complications- postoperative surgical before discharge 1 kidney / urinary, 1 liver / gi, 6 not documented.Surgical complications- intraoperative adverse events 1 nerve root damage, 3 dural lesion.Surgical complications- postoperative surgical before discharge 2 other hematoma, 1 radiculopathy, 1 csf leak / pseudo meningocele, 2 motor dysfunction, 1 sensory dysfunction, 2 other, 4 not documented, 1 implant malposition.Reoperations : number of reoperations at any level (27) 6 adjacent segment pathology, 3 failure to reach therapeutic goals, 1 implant failure, 1 instability, 6 neuro- compression, 2 non-union, 3 other, 1 sagittal imbalance, 15 unknown.Number of reoperations at the same level (4) 2 failure to reach therapeutic goals, 2 neuro- compression, 2 non-union, 1 other.This is for depuy synthes zero-p, pro disc c, prodisc vivo, prodisc-nova and chronos.The complaint involves 12 devices.Due to a limit of impacted products per complaint, this complaint will be captured under 2 separate complaints as listed below: (b)(4) this complaint will include 10 devices ¿ 5 unk - constructs: zero-p , and 5 unk - biomaterial - preformed: chronos: spine (1st pc).(b)(4) this complaint will include 2 devices ¿1 unk - constructs: zero-p , and 1 unk - biomaterial - preformed: chronos: spine (2nd pc).This report involves one (1) unk - biomaterial - preformed: chronos: spine.This report is 3 of 6 for (b)(4).
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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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