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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 7.0 X 45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE SCREW 7.0 X 45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 199721745
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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 that on (b)(6) 2019, during insertion of the innie, the innie did not align properly and positioned itself into a displaced part of screws´s thread.There was no surgical delay and there was no patient consequence.This complaint involves four (4) devices.
 
Manufacturer Narrative
Product complaint #
=
> (b)(4)., h4.
 
Manufacturer Narrative
Product complaint #
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> (b)(4).Udi: (b)(4).Visual examination of the returned device found the extended tabs with loading zone were returned separately from the device.Upon visual inspection, it was observed that the drive feature between the hypermobile head and the threaded dual lead shank was jammed and seized.The internal threads of the head were observed to be stripped.No other issues were identified with the returned components of the device.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.There was no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
5.5 EXP VERSE SCREW 7.0 X 45
Type of Device
ORTHOSIS, 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
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8803895
MDR Text Key151478779
Report Number1526439-2019-51843
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034442105
UDI-Public(01)10705034442105
Combination Product (y/n)N
PMA/PMN Number
K142185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 06/26/2019
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? Yes
Device Operator Health Professional
Device Model Number199721745
Device Catalogue Number199721745
Device Lot Number216837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/26/2019
Initial Date FDA Received07/18/2019
Supplement Dates Manufacturer Received08/22/2019
09/18/2019
Supplement Dates FDA Received09/16/2019
09/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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