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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Migration (4003)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Nerve Damage (1979); Non-union Bone Fracture (2369); Osteolysis (2377); Impaired Healing (2378); Joint Laxity (4526); 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.H10 additional narrative: b3: unknown event date d1, d2, d3, d4, g4-510k: this report is for an unknown unk - constructs: viper/unknown lot.Part and lot number are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: reporter is a synthes employee.H6: 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) 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.

• Brand Name: UNK - CONSTRUCTS: VIPER
• Type of Device: ORTHOSIS, PEDICLE SPINAL FIXATION
• 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 ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19049716
• MDR Text Key: 339555314
• Report Number: 1526439-2024-01228
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/05/2024
• 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