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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 09/13/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Visual inspection of the returned device found half the threads on opposite sides are completely broken. Shear marks are apparent on the core. The fragments of the threads were not returned. The core and threads were discolored. 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. Although no definitive root-cause can be determined, it is possible that the device experienced unintended forces due to over-torque / off-axis tightening. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. 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.
 
Event Description
A female patient, born (b)(6), was treated today ((b)(6) 2019) with the expedium verse 'adavanced' set (orthokit, see screenshot of reservation) at l3-l4. When the correction cap was inserted, it was tilted in the long head of the expedium verse advanced screw so much that the long thread of two screws was defective and a total of 6 correction caps were defective. At the final tightening with torque of the inner adjusting screw in one situation the inner adjusting screw was so defective that it broke. Surgical delay about 1 hour, procedure was completed with modular end caps after they changed two screws.
 
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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 INTERNATIONAL SàRL CH
chemin-blanc 38
le locle
SZ
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9327668
MDR Text Key180400030
Report Number1526439-2019-52436
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,Followup
Report Date 09/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number199721000
Device Lot Number128220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2017
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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