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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 8 X 50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 8 X 50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 179712850
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2022
Event Type  Injury  
Manufacturer Narrative
Initial reporter is synthes sales representative. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
It was reported on (b)(6) 2022, during spinal fusion surgery the tip of the quick connect driver broke off inside an 8x50mm screw while the surgeon was inserting the screw. The surgeon removed the head to try removal with a srb set. The screw shank was unable to be extracted from the patient. Fragments were generated. There was a surgical delay of forty-five (45) minutes. Procedure was completed successfully. Patient status is unknown. This complaint involves two (2) devices. This is report 1 of 2 for (b)(4).
 
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Brand NameEXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 8 X 50MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key13902720
MDR Text Key287903814
Report Number1526439-2022-00456
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034068084
UDI-Public(01)10705034068084
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101993
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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 Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number179712850
Device Catalogue Number179712850
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2022
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: 03/25/2022 Patient Sequence Number: 1
Treatment
XPDM QUICK-CON SI POLY SCWDRVR
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