MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: VIPER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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); Failure of Implant (1924); Nerve Damage (1979); Perforation of Vessels (2135); Non-union Bone Fracture (2369); Osteolysis (2377); Spinal Cord Injury (2432); Post Operative Wound Infection (2446); Thromboembolism (2654); Decreased Sensitivity (2683); Vertebral Fracture (4520); Joint Laxity (4526); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Insufficient Information (4580)

Event Type  Injury  

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).The following complications have been identified: general complications - intraoperative: 3 patients had anaesthesiological, 3 patients had cardiovascular, 1 patient had pulmonary.General complications-postoperative: 3 patients had cardiovascular, 1 patient had pulmonary, 2 patients had cerebral, 5 patients had kidney/urinary, 2 patients had liver/gi, 2 patients had thromboembolism, 4 patients had other complications.Surgical complications - intraoperative: 5 patients had nerve root damage, 30 patients had dural lesion, 1 patient had vascular injury, 1 patient gad fracture vertebral structures, 3 patients had other complications.Surgical complications - postoperative: 1 patient had epidural hematoma, 1 patient had other hematoma, 1 patient had radiculopathy, 1 patient had csf leak/ pseudomeningocele, 2 patients had motor dysfunction, 2 patients had sensory dysfunction, 2 patients had wound infection deep, 3 patients had implant malposition, 1 patient had implant failure, 3 patients had other complications.Postoperative complications: 7 patients had sensory dysfunction, 5 patients had motor dysfunction, 1 patient had bowel/bladder dysfunction, 3 patients had non-union, 4 patients had implant failure, 2 patients had instability, 4 patients had wound infection superficial, 1 patient had extravertebral hematoma, 3 patients had implant malposition, 5 patients had adjacent segment pathology, 1 patient had decompression of spine, 1 patient had cardiovascular, 4 patients had fracture vertebral structures, 3 patients had other complications.Reoperations: 24 patients had reoperation at any level, 8 patients had reoperation at an adjacent level, 13 patients had reoperations at same level, 7 patients had reoperation due to hardware removal, 1 patient had reoperation due to non-union, 3 patients had reoperation due to instability, 2 patients had reoperation due to neuro-compression, 1 patient had reoperation due to postoperative infection deep, 1 patient had reoperation due to implant malposition, 3 patients had reoperation due to implant failure, 5 patients had reoperation due to adjacent segment pathology, 6 patients had reoperation due to other complications, 7 patients had reoperation due to unknown complications.This is for depuy spine viper constructs.This is report 1 of 1 for complaint (b)(4).

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 spine viper constructs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j employee.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

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 (b)(4) patients ((b)(4) procedures; (b)(4) male and (b)(4) female; mean age was 64.3 years) from (b)(6) 2012 to (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5 h6 updated coding 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.

• Brand Name: UNK - CONSTRUCTS: VIPER
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 15619427
• MDR Text Key: 301898854
• Report Number: 1526439-2022-01822
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention