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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN CAGE/SPACER

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MEDOS INTERNATIONAL SàRL CH UNKNOWN CAGE/SPACER Back to Search Results
Device Problems Break (1069); Migration (4003)
Patient Problem No Code Available (3191)
Event Date 11/28/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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 was reported :event outcome/how was it managed? the screw was removed and a larger diameter (7x40) was inserted in its place. The l3 screw was present from a previous fusion: l2-s2ai with xlifs at l2/3, l3/4 & l4/5. The screw was removed and it became clear the tip of the screw had snapped due to the subsidence of the titanium cage above at the 2/3 disc space. In subsiding the cage had collided with the screw and broken it. This was highlighted to mr (b)(6) and as the broken fragment was some way into the vertebral body he opted to leave it in situ inserting a shorter screw with a wider diameter to avoid hitting the fragment.
 
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. All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting. Without the return of the device, we are unable to confirm the reported issue or identify the root cause. As no systemic trends were found, 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.
 
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Brand NameUNKNOWN CAGE/SPACER
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 Key8174054
MDR Text Key130682380
Report Number1526439-2018-51155
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
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 Received02/22/2019
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? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/18/2018 Patient Sequence Number: 1
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