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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 186715000
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Visual examination found that the threads on the set screw were completely torn off. 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. With the information provided, a definitive root cause for the torn threads on the single-inner set screw cannot be determined. Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head. 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
Dr (b)(6), expedium si set screws ¿ 186715000, open-closed connector - 179755155: repeatedly stripping. Procedure was completed by using multiple locking screws. No patient complications. Operation was completed as expected. 15 minute delay to the procedure.
 
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Brand NameMIS SINGLE INNER SETSCW
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 MA
SZ
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9265614
MDR Text Key185077721
Report Number1526439-2019-52352
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034121192
UDI-Public10705034121192
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K160904
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 06/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number186715000
Device Lot Number235684
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2019
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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