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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE SCREW 6.0 X 50 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE SCREW 6.0 X 50 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 199721650
Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2020
Event Type  malfunction  
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a (b)(6). 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
Device report from synthes reports an event in germany as follows: it was reported that on (b)(6), 2020, a patient was treated with exp verse due to a deformation of the spine from t4-l4. During the first part correction a rod was placed at the lower part and the screws were fixated with a verse correction key through which a mono-axiality was created. The verse correction keys were not tightened with a torque limited but only tightened softly by hand to normal soften tightening of the rod without final locking. After loosening the verse correction keys the mono-axiality was not revoked and the mono-block continued to exist. No de-rotation was performed until then. The l4 exp verse 7mm pedicle screw broke through and all screws needed to be replaced with bigger screws as the pedicle fracturing caused all 4 screws become locked mono-axial characteristics after removing the temporary rod. There was surgical delay of forty (40) minutes due to the reported event. Procedure was completed successfully. This report is for one (1) 5. 5 exp verse screw 6. 0 x 50. This is report 4 of 5 for complaint (b)(4).
 
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Brand Name5.5 EXP VERSE SCREW 6.0 X 50
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)
BRIDGEWATER DISTRIBUTION
50 scotland boulevard
bridgewater MA 02324
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10906358
MDR Text Key228943422
Report Number1526439-2020-02293
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034442266
UDI-Public(01)10705034442266
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K142185
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,Followup,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number199721650
Device Catalogue Number199721650
Device Lot Number277886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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