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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREWS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREWS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
There were 25 men and 55 women with a mean age of 67.71 years (range, 54-80 years).510k: this report is for an unknown depuy spine 5.5 mm viper cortical fix fenestrated screw system/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.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.(b)(4).
 
Event Description
This report is being filed after the review of the following journal article: feng s, et al.(2019), effect of robot-assisted surgery on lumbar pedicle screw internal fixation in patients with osteoporosis, world neurosurgery, volume 125, page e1057-e1062 (china).The objective of this study was to compare radiologic and clinical outcomes obtained with robot-assisted versus conventional freehand fluoroscopy-assisted pedicle screw insertion in patients with osteoporosis.Between june 2016 and july 2018,80 patients with osteoporosis and lumbar disease who underwent treatment with pedicle screw fixation were included in the study.There were 25 men and 55 women with a mean age of 67.71 years (range, 54-80 years).Patients were randomized 1:1 to undergo fluoroscopy-assisted freehand pedicle screw placement (control group) or robot-assisted pedicle screw placement (experimental group).In the experimental group, 40 patients (12 men and 28 women) with a mean age of 67.55 years (range, 54-78 years) underwent robot-assisted pedicle screw insertion.In the control group, 40 patients (13 men and 27 women) with a mean age of 67.88 years (range, 54-80 years) underwent freehand fluoroscopy-assisted pedicle screw insertion.All patients were implanted with the unknown depuy spine viper cortical fix fenestrated screw system, 5.5 mm (depuy synthes, raynham, massachusetts, usa).A total of 427 pedicle screws were inserted in 80 patients; 202 pedicle screws were inserted in the experimental group, and 225 pedicle screws were inserted in the control group.Complications were reported as follows: (experimental group): 3 screws had a cortical breach of less than 2mm.(control group): 18 screws had a cortical breach of less than 2mm.1 screw had a cortical breach of more than 2mm.7 screws were revised intraoperatively.This report is for an unknown depuy spine 5.5 mm viper cortical fix fenestrated screw system.This is report 1 of 1 for (b)(4).
 
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Brand Name
UNKNOWN SCREWS
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9866486
MDR Text Key193296035
Report Number1526439-2020-00750
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/25/2020
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/25/2020
Initial Date FDA Received03/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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