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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN PLATES PLATE,FIXATION,BONE

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MEDOS INTERNATIONAL SàRL CH UNKNOWN PLATES PLATE,FIXATION,BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/17/2020
Event Type  malfunction  
Manufacturer Narrative
This report is for an unk - plates/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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
Device report from (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for a surgery. During the surgery, the screws were falling of the screwdriver. The scrub nurse had problems while picking up screws from the screw caddy as they were sinking into the top plastic layer where they got stuck and were hard to get out. Upon examination of the screw caddy we noticed that the top plate is elevated and the screws that are holding it in place are holding it are deformed/displaced. During the surgery (2 level), some of the screws had to be replaced with large diameter screws. Surgeon was unable to remove 3 of the screws and had to leave them in place although they were not fixated in the bone ¿ he managed to unscrew them but could not take them out of the bone/skyline plate. They had to finish the surgery with the 3 screws not fixed into the bone but locked into the plate. The procedure was completed successfully with 45 minutes delay. There were no patient consequences. This complaint involves ten (10) devices. This report is for (1) unknown plates. This is report 6 of 9 (b)(4).
 
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Brand NameUNKNOWN PLATES
Type of DevicePLATE,FIXATION,BONE
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 02400
SZ   02400
6103142063
MDR Report Key10529340
MDR Text Key206795859
Report Number1526439-2020-01660
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received10/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/14/2020 Patient Sequence Number: 1
Treatment
MEDIUM X15 TAPERED DRIVER.; MEDIUM X15 TAPERED DRIVER.; SKY VARIABLE S-D SCW 13MM TI.; SKY VARIABLE S-D SCW 14MM TI.; SKY VARIABLE SCW CADDY.; UNKNOWN PLATES.
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