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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREWS

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MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREWS Back to Search Results
Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 05/13/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Udi: unavailable, unknown. 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
It was reported that on (b)(6) 2019, after sterilization, after replacement of the screws, the or nurse wanted them to be sterilized for demonstration purpose. After sterilization two (2) of the three (3) screws fell apart in 3 pieces. There was no patient involvement. This complaint involves two (2) devices.
 
Manufacturer Narrative
(b)(4). Device was not returned for evaluation. A review of the device history record could not be performed as the lot number is unknown. Without the return of the device, we are unable to confirm the reported issue or identify the root cause. This complaint file will be closed with no further action required. Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameUNKNOWN SCREWS
Type of DeviceUNKNOWN
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 Key8667976
MDR Text Key147306631
Report Number1526439-2019-51722
Device Sequence Number1
Product Code NKB
UDI-Public(01)UNAVAILABLE
Combination Product (y/n)N
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,Followup
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/04/2019 Patient Sequence Number: 1
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