MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM VERSE; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Osteolysis (2377)

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) of a total of 50 patients (30 males and 20 females) with an average age of 61 years treated between september 2019 and august 2020 with the depuy synthes expedium verse system, this constituted the expedium verse cohort.The average length of follow-up was 11.3 months (0-24 months).A subset of 33 patients were implanted with the depuy synthes expedium verse system and t-pal proti system (t-pal proti cohort).The average age of the t-pal proti cohort was 61 years with 11 females and 22 males.The average length of post-operative follow-up was 11.9 months.Within the expedium verse cohort, interbody cages was used.Patients received t-pal proti (66%), conduit tlif (2%), femoral ring allograft (fra)(12%), and no interbody cage (20%).Complications, reoperations, and revision were described below: 5 patients experienced complications resulting in 6 operations in 4 patients: 2 of these patients experienced supra-adjacent breakdown with stenosis requiring.Extension of their previous fusion at 12 and 14 months after their index surgery.1 of these patients developed a deep venous thrombosis (dvt) and pulmonary embolism in the first six weeks after surgery.The patient was treated with anti-coagulation for 6 months and otherwise recovered uneventfully.None of these complications are thought to be device related.1 (male) of these patients developed a psoas abscess that tracked anteriorly to his spine implants at 24 months post-operatively which was treated with posterior implant removal and wound vac placement with two subsequent irrigations and closure.The psoas abscess was treated with anterior drain placement.The infection cleared within 6 weeks of intravenous antibiotics and with uneventful wound healing.At subsequent surgery, the fusion mass was observed to be solid.1 patient was readmitted from an outside hospital 10 days post-operatively with signs of sepsis (hypotension, hypoxia, fever).An mri suggested a deep wound infection which required reoperation with a wound exploration.No infection was found in the wound.This patient has a history of dvt and was morbidly obese resulting in preoperative treatment with a vena cava filter.It was found that the patient had developed extensive clotting distal to his filter causing a caval occlusion.The patient died of cardiac collapse two weeks after surgery.This complication was not device related.Additionally, the fusion status of this patient was considered to be not fused (table 10).This is report 2 of 4 for (b)(4).This is for depuy spine expedium verse pedicle screw system.A copy of the clinical evaluation form is being submitted with this regulatory report.

Manufacturer Narrative

Brand name, common device name, manufacture name, city and state, lot #, pma/510k: this report is for an unknown mono/polyaxial screws (expedium verse)/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Concomitant medical products: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative (medical affairs).Device evaluated by mfr and device manufacture date: 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.

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM VERSE
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS 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: 14273758
• MDR Text Key: 293622616
• Report Number: 1526439-2022-00659
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,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

• Date FDA Received: 05/04/2022
• 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?: Yes
• Date Manufacturer Received: 04/04/2022
• 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