MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREWS: EXPEDIUM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Inadequate Osseointegration (2646)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 the following journal article: tosic l, et al (2019), decompression and dynamic transpedicular stabilization using polyetheretherketone rods and pedicle screws vs.Decompression alone for single-level spinal canal stenosis with listhesis: a retrospective case-control study, j neurol surg a, volume 80, pages 454¿459 (germany).The aim of this study was to assess the outcomes of the patients who received microsurgical decompression and dynamic dorsal spondylodesis using peek rods and compare them with the outcomes of patients who received microsurgical decompression alone for treatment of spinal canal stenosis and grade i (meyerding grade i) spondylolisthesis.From january 2012 to december 2016, 20 patients undergoing microsurgical decompression and dorsal dynamic transpedicular stabilization using polyetheretherketone (peek) rods were included in the study.There were 20 patients with the same diagnosis undergoing microsurgical decompression alone and they were used as controls.In the target group, there were 5 males and 15 females with a mean age of 72.5 years, and they underwent dorsal open microsurgical decompression and additional transpedicular dynamic stabilization using thee unknown depuy spine expedium spine system.Complications were reported as follows: 2 patients had symptomatic screw loosening of the right l5 pedicle.1 presented with back pain at 6 months postoperatively; the other presented with right-sided l5 radicular pain at 9 months postoperatively.In both patients, the screws were replaced and the symptoms resolved.1 patient had a screw loosening in l4 at 12 months postoperatively that could be managed conservatively.Patient also had listhesis that progressed by 3 mm.6 patients were still using analgesics at the 3-month follow-up interval.3 patients used analgesics at 12 months postoperatively.1 patient had paresthesia in the left l4 dermatome, and the deficit did not resolve postoperatively.This report is for a unk - screw: expedium.A copy of the clinical evaluation form is being submitted with this regulatory report.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - SCREWS: EXPEDIUM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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 ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14851700
• MDR Text Key: 294910757
• Report Number: 1526439-2022-00959
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• 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: 06/01/2022
• 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