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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
This report is against user facility medwatch number mw5090961. The only information contained in this report is correction or additional information. This report is for an unknown spine screw/unknown lot. Part and lot numbers are unknown; udi number is unknown. Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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. (b)(4).
 
Event Description
Initial report of event was reported from patient under fda complaint form mw5090961: it was reported that on (b)(6) 2014, the patient broke their back from a fall and was implanted with a titanium rod, six (6) screws, and two (2) squirrel cages. The patient experienced pain, rash, hives, and itching at surgery site immediately post-operatively. The symptoms continued to worsen and the patient started having anaphylaxis episodes requiring allergic reaction treatment. Allergy tests completed confirmed the patient was highly 3++ allergic to titanium, nickel, cobalt, and magnesium. Hardware revision surgery occurred on (b)(6) 2019 and the rod was removed. The patient continues to have allergic reactions post revision surgery. This is report 8 of 10 for (b)(4). This report is for an unknown screw.
 
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Brand NameUNKNOWN SCREWS
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9553487
MDR Text Key189435366
Report Number1526439-2020-00176
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 other
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
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?
Type of Device Usage Unkown

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