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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORELINK SURGICAL, LLC F3D CERVICAL STAND-ALONE; F3D CERVICAL STAND-ALONE CAGE
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CORELINK SURGICAL, LLC F3D CERVICAL STAND-ALONE; F3D CERVICAL STAND-ALONE CAGE Back to Search Results
Model Number 3CS1614-0706
Device Problems Mechanical Problem (1384); Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2021
Event Type  malfunction  
Event Description
It was reported that during a case, a screw went through the side wall of the cage.The screws and implant were able to be removed and successfully replaced.There was no adverse event, and a 10-15 minute delay in surgery was reported.
 
Manufacturer Narrative
The returned devices were inspected, at which time it was determined that all returned parts were conforming to print.Historical reviews showed that there have been no other complaints filed for this device, nor this reported issue in the device family.A specific root cause was unable to be determined.Correctively, the returned devices will be held indefinitely.Preventively, the print is in the process of being updated to reinforce the wall that became damaged in this case.
 
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Brand Name
F3D CERVICAL STAND-ALONE
Type of Device
F3D CERVICAL STAND-ALONE CAGE
Manufacturer (Section D)
CORELINK SURGICAL, LLC
2072 fenton logistics park
fenton MO 63026
MDR Report Key12380162
MDR Text Key280784669
Report Number3006494201-2021-00005
Device Sequence Number1
Product Code OVE
UDI-Device IdentifierM7253CS161407060
UDI-Public+M7253CS161407060/$$7SM1169845
Combination Product (y/n)N
PMA/PMN Number
K200087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Other
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3CS1614-0706
Device Lot NumberSM116984
Date Manufacturer Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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