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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SàRL CH UNK - SCREWS: EXPEDIUM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
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).
 
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Brand NameUNK - SCREWS: EXPEDIUM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL 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 Key14851700
MDR Text Key294910757
Report Number1526439-2022-00959
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/29/2022 Patient Sequence Number: 1
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