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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. MESA SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM
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K2M, INC. MESA SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 3001-84545N
Device Problems Difficult to Remove (1528); Mechanics Altered (2984)
Patient Problem No Information (3190)
Event Date 04/21/2015
Event Type  Injury  
Event Description
Manufacturer was made aware that during a patient planned revision, the surgeon was not able to remove the connector set screws which are usually removed and replaced.The surgeon decided to leave the connector in the patient, was not able to re-tighten the set screws as they were stripped and put a cross connector in to stabilize the construct.
 
Manufacturer Narrative
Manufacturer was made aware that during a patient planned revision, the surgeon was not able to remove the connector set screws which are usually removed and replaced.The surgeon decided to leave the connector in the patient, was not able to re-tighten the set screws as they were stripped and put a cross connector in to stabilize the construct.The device evaluation is anticipated, but not yet begun.Manufacturer will file a follow-up report once new information becomes available.Disposition of device to be determined.
 
Manufacturer Narrative
Follow-up #1/final report issued to include additional information as indicated below.Follow-up actions indicate that the patient is doing well, k2m inc does not expect to receive additional information in regards to this case and then, considers this to be a close-out report.The implants remain in the patient and could not be evaluated.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.The incident could not be recreated.Cross threading could have contributed to the incident.The set screws of the implants are not designed to be removed.Attempting to remove the set screws can damage the threads of the connector and is consistent with misuse.There is not a firm conclusion regarding this event since the subject part(s) were not returned for evaluation.The risk (common risk analysis, risk-000 rev 7: hazard analysis, pha lines: 109-124: rod connector is damaged and/or breaks, lines 145-156: set screw is damaged, cross threaded, and/or breaks, and lines 157-158: set screw does not function as intended) was reviewed and determined that addresses the scenario described in this case.The probability and severity associated with these hazards are found to be accurately assigned.No edits are required.Technique: the surgical technique guide and ifu are accurate and available to the surgeon - no edits required.Device remains in patient.
 
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Brand Name
MESA SPINAL SYSTEM
Type of Device
PEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
K2M, INC.
751 miller dr se
suite f-1
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
751 miller dr se
suite f-1
leesburg VA 20175
Manufacturer Contact
sandra gilbert
751 miller dr se
suite f-1
leesburg, VA 20175
5719192195
MDR Report Key4789200
MDR Text Key18092111
Report Number3004774118-2015-00023
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3001-84545N
Other Device ID Number10888857052437
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/22/2015
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 Initial
Patient Sequence Number1
Treatment
(B)(4): ROD CONNECTOR LOT:TBD
Patient Outcome(s) Required Intervention;
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