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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown screw/rod construct accessories/unknown lot. Part and lot number 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. (b)(4). 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: goertz l. , et al (2020) impact of obesity on complication rates, clinical outcomes, and quality of life after minimally invasive transforaminal lumbar interbody fusion, journal of neurological surgery part- a volume 82, pages 147¿153 (germany). This retrospective, observational, single-center study aims to compare surgical complications, long-term pain outcome, and hrqol between obese and nonobese patients who underwent mistlif for degenerative spine disease. Between 2011 and 2014, 71 patients (50 females,21 males) age 64. 6-10. 8 years underwent mis-tlif at a high volume tertiary care hospital. All patients were treated by the mis-tlif technique using polyaxial pedicle screws (viper 2 system, depuy synthes, raynham, massachusetts, united). The target disk was removed, and a peek cage (tpal, depuy synthes) filled with autologous bone chips was placed in the anterior third of the intervertebral space under fluoroscopic guidance. Follow-up duration (mo) 53. 4 -12. 8. The following complications were reported: 9 dural tears. 1wound infection. 1 rebleeding. Patients with postoperative neurological deficits (1 with a motor deficit, 1 with a sensory deficit, and 2 patients with a motor-sensory deficit). 13 revision surgery. Screw avulsion or breakage in 5 patients. Cage migration and screw avulsion or breakage in 2 patients. Screw accuracy: n=10) grade 2, <2mm threads outside the pedicle. N=5) grade 3: 2 to 4mm of core screw diameter outside the pedicle. This report is for an unknown depuy spine polyaxial pedicle screws (viper 2 system). This is report 1 of 4 for (b)(4). Additional reports are captured under (b)(4).

 
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Brand NameUNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 
SZ  
6103142063
MDR Report Key12313073
MDR Text Key266225161
Report Number1526439-2021-01669
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 07/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/12/2021 Patient Sequence Number: 1
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