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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK SCREWS
Device Problems Break (1069); Device Slipped (1584)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown screw/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, a spondylodese was reported with broken and loose screws. The screws were replaced. Patient status is unknown. This report is for one (1) unknown screws. This is report 3 of 6 for (b)(4).
 
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Brand NameUNKNOWN SCREWS
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 Key14084028
MDR Text Key289073271
Report Number1526439-2022-00557
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK SCREWS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2022
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: 04/12/2022 Patient Sequence Number: 1
Treatment
MIS TI CFX FEN POLY 10X50; MIS TI CFX FEN POLY 10X50; MIS TI CFX FEN POLY 6X45; MIS TI CFX FEN POLY 6X45; MIS TI CFX FEN POLY 8X50; MIS TI CFX FEN POLY 9X45
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