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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VERSE CORRECTION KEY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH VERSE CORRECTION KEY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 199721000
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Not Applicable (3189)
Event Date 08/14/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Visual inspection of the returned device found the thread on the device peeling and discoloration was observed. Rest of the device showed no signs of damage. A review of the device history record could not be performed as the part number/lot number combination could not be found. The complaint condition was confirmed as the threads of verse correction key were peeling, which could have contributed to the complaint condition. There was no indication that a design or manufacturing issue has caused the peeled threads and hence the root cause cannot be determined. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.
 
Event Description
After the first final tightening of the correction cap screws with the torque, after 20 op - minutes it came to a decrease of the potentials in the neuromonitoring so that the correction had to be taken back. It was no longer possible to loosen the screw heads of the screws listed above - cold welding. The implants had to be removed and replaced by new ones. All correction cap screws had to be loosened and replaced. The insertion of these was difficult because the correction cap screws skipped threads when inserted into the screw head. Diagnosis: right convex thoracic scoliosis. The surgery delayed for about 60 minutes. The surgery finished successfully.
 
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Brand NameVERSE CORRECTION KEY
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
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9290272
MDR Text Key179792385
Report Number1526439-2019-52367
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466132
UDI-Public10705034466132
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
Type of Report Initial
Report Date 08/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number199721000
Device Lot Number245767
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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