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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 6.0 X 45 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE SCREW 6.0 X 45 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 199721645
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Additional product code : kwp;kwq;mnh;mni;osh. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Investigation summary: photo investigation: the device was not returned. A photo-investigation was performed on the images. An issue with the verse screw could not be detected with the image provide. No other issues were noted. As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed. Conclusion: the complaint was not confirmed. During the investigation, no product design issues or discrepancies were observed. No manufacturing issues were noted during investigation. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Therefore, it has been determined that no corrective and/or preventive action is proposed. Device history lot: the dhr of product code 199721645, lot 264237, was reviewed and no non-conformances were observed during the manufacturing process. The product was released on december 2, 2019. Qty. (b)(4). The dhr was electronically reviewed. Device history review: a manufacturing issue was not observed during dhr review. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery. During the surgery, of posterior lumbar internal fixation, when final tightened the inner set screw, the thread was peeled. The surgeon also removed verse screw which was connect with the inner set screw. It was unknown if the surgery completed successfully. There were no patient consequences are reported. Concomitant device reported: unknown tightener (part# unknown, lot# unknown, quantity unknown ). This complaint involves two (2) devices. This report is for (1) 5. 5 exp verse screw 6. 0 x 45. This report is 1 of 2 (b)(4).
 
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Brand Name5.5 EXP VERSE SCREW 6.0 X 45
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
BRIDGEWATER DISTRIBUTION
50 scotland boulevard
bridgewater MA 02324
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key11599691
MDR Text Key243353271
Report Number1526439-2021-00602
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034442273
UDI-Public10705034442273
Combination Product (y/n)N
Reporter Country CodeCH
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 03/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number199721645
Device Catalogue Number199721645
Device Lot Number264237
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2019
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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