MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: VIPER; ORTHOSIS, PEDICLE SPINAL FIXATION
|
Back to Search Results |
|
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Migration (4003)
|
Patient Problems
Cerebrospinal Fluid Leakage (1772); Bone Fracture(s) (1870); Hematoma (1884); Nerve Damage (1979); Post Operative Wound Infection (2446); Thromboembolism (2654); Decreased Sensitivity (2683); Unspecified Tissue Injury (4559); Insufficient Information (4580)
|
Event Type
Injury
|
Manufacturer Narrative
|
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.This report is for an unknown unk - constructs: viper/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.E1: reporter is a synthes 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.
|
|
Event Description
|
This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra): spine tango implant report - viper (all) in a total of 1058 patients (1069 procedures; 456 male and 613 female; mean age was 64.3 years) from (b)(6) 2024.The following complications have been identified per country: switzerland (n=239) intraoperative general complications: (n=4) anaesthesiological 4 (n=3) cardiovascular (n=1) other (n=1) pulmonary postoperative general complications - before discharge: (n=3) cardiovascular (n=5) other (n=1) pulmonary (n=2) cerebral (n=6) kidney / urinary (n=2) liver / gi (n=3) thromboembolism intraoperative surgical complications (n=67) dural lesion (n=6) fracture vertebral structures (n=8) nerve root damage (n=13) other postoperative surgical complications - before discharge: (n=4) other (n=1) csf leak / pseudomeningocele (n=1) epidural hematoma (n=1) implant failure (n=3) implant malposition (n=2) motor dysfunction (n=1) other hematoma (n=1) radiculopathy (n=3) sensory dysfunction (n=2) wound infection deep surgery follow-up complications - early (< 28 days): (n=1) adjac.Segment pathology (n=1) bowel/ bladder dysfunction (n=1) cardiovascular (n=1) extravertebral hematoma (n=3) fracture vertebral structures (n=2) implant failure (n=2) implant malposition (n=3) motor dysfunction (n=1) other (n=4) sensory dysfunction surgery follow-up complications - sub-acute (2-6 months): (n=2) adjac.Segment pathology (n=1) fracture vertebral structures (n=1) motor dysfunction (n=2) non-union (n=2) sensory dysfunction (n=2) wound infection superficial surgery follow-up complications - late (> 6 months): (n=1) instability reoperations at any level due to: (n=8) adjacent segment pathology (n=1) csf-leak (n=5) instability (n=8) implant failure (n=10) hardware removal (n=3) non-union (n=1) spinal imbalance (n=1) postoperative infection superficial (n=3) implant malposition (n=4) neurocompression (n=2) postoperative infection deep (n=1) wound healing problem (n=8) other (n=10) unknown reoperations at adjacent level due to: (n=7) adjacent segment pathology (n=4) instability (n=5) implant failure (n=5) hardware removal (n=2) non-union (n=1) spinal imbalance (n=1) postoperative infection superficial (n=2) neurocompression (n=5) unknown reoperations at same level due to: (n=5) adjacent segment pathology (n=1) csf-leak (n=3) instability (n=7) implant failure (n=5) hardware removal (n=2) non-union (n=1) spinal imbalance (n=1) postoperative infection superficial (n=3) neurocompression (n=4) other (n=5) unknown portugal (n=2) surgery follow-up complications - late (> 6 months): (n=1) cardiovascular (n=1) other this is for unknown depuy spine viper.
|
|
Manufacturer Narrative
|
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.H11: additional narrative: b5 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.
|
|
Event Description
|
Updated event description: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra): spine tango implant report - viper (all) in a total of 1153 patients (1167 procedures; 498 male and 669 female; mean age was 64.3 years) from october 15, 2012 to march 11, 2024.The following complications have been identified per country: switzerland (n=253) intraoperative general complications: (n=4) anaesthesiological 4 (n=3) cardiovascular (n=1) other (n=1) pulmonary (n=1) thromboembolism postoperative general complications - before discharge: (n=3) cardiovascular (n=5) other (n=1) pulmonary (n=2) cerebral (n=6) kidney / urinary (n=2) liver / gi (n=3) thromboembolism intraoperative surgical complications (n=69) dural lesion (n=6) fracture vertebral structures (n=8) nerve root damage (n=14) other postoperative surgical complications - before discharge: (n=4) other (n=1) csf leak / pseudomeningocele (n=1) epidural hematoma (n=1) implant failure (n=3) implant malposition (n=2) motor dysfunction (n=1) other hematoma (n=1) radiculopathy (n=3) sensory dysfunction (n=2) wound infection deep surgery follow-up complications - early (< 28 days): (n=1) adjac.Segment pathology (n=1) bowel/ bladder dysfunction (n=1) cardiovascular (n=1) extravertebral hematoma (n=3) fracture vertebral structures (n=2) implant failure (n=2) implant malposition (n=3) motor dysfunction (n=1) other (n=4) sensory dysfunction surgery follow-up complications - sub-acute (2-6 months): (n=2) adjac.Segment pathology (n=1) fracture vertebral structures (n=1) motor dysfunction (n=2) non-union (n=2) sensory dysfunction (n=2) wound infection superficial surgery follow-up complications - late (> 6 months): (n=1) instability reoperations at any level due to: (n=8) adjacent segment pathology (n=1) csf-leak (n=5) instability (n=9) implant failure (n=11) hardware removal (n=3) non-union (n=2) spinal imbalance (n=1) postoperative infection superficial (n=4) implant malposition (n=5) neurocompression (n=1) failure to reach therapeutic goals (n=3) postoperative infection deep (n=1) wound healing problem (n=10) other (n=11) unknown reoperations at adjacent level due to: (n=7) adjacent segment pathology (n=4) instability (n=6) implant failure (n=6) hardware removal (n=2) non-union (n=2) spinal imbalance (n=1) postoperative infection superficial (n=1) implant malposition (n=3) neurocompression (n=1) failure to reach therapeutic goals (n=1) postoperative infection deep (n=2) other (n=6) unknown reoperations at same level due to: (n=5) adjacent segment pathology (n=1) csf-leak (n=3) instability (n=8) implant failure (n=6) hardware removal (n=2) non-union (n=2) spinal imbalance (n=1) postoperative infection superficial (n=1) implant malposition (n=4) neurocompression (n=1) failure to reach therapeutic goals (n=1) postoperative infection deep (n=6) other (n=6) unknown portugal (n=3) surgical postoperative (before discharge) complications: (n=10) implant failure surgery follow-up complications - late (> 6 months): (n=1) cardiovascular (n=1) other.
|
|
Search Alerts/Recalls
|
|
|