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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
Model Number 199721000
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).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
The following event was reported: both screwdriver part codes fail at the moment of blocking the expedium verse system, when reviewing the distal tip it is evidence that it deteriorated despite being a new instrument.At the moment of placing the double-pass bushes (code: 199721000) with the screwdrivers, they are stolen.It tries to close, and the screwdrivers do not work with the torque handle 299704320.The surgeon wants to close and notices that the cap is damaged place another bushing and when you want to do the final torque the x25 inserter screwdriver piece does not block.The surgery was extended for approximately 5 hours.
 
Manufacturer Narrative
Product complaint #
=
> (b)(4).Visual examination of the correction key revealed signs of operative use as evidence by superficial markings, with threads and drive feature worn/damaged but not torn.It was noted that the base of the correction key appears warped.Mechanical forces on the correction key would have resulted in the base becoming warped.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 a definitive root cause for the threads of the correction key becoming worn/warped cannot be positively determined.However, the noted damage suggests that the correction keys were likely subjected to unanticipated mechanical forces during the tightening process, resulting in the base becoming warped.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
VERSE CORRECTION KEY
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 Key8558291
MDR Text Key143386153
Report Number1526439-2019-51576
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466132
UDI-Public(01)10705034466132
Combination Product (y/n)N
Reporter Country CodePE
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
Report Date 03/08/2019
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 Number199721000
Device Catalogue Number199721000
Device Lot Number226150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/02/2019
Initial Date FDA Received04/26/2019
Supplement Dates Manufacturer Received06/03/2019
Supplement Dates FDA Received06/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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