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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. CASPIAN OCT SPINAL SYSTEM; SPINAL FIXATION SYSTEM

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K2M, INC. CASPIAN OCT SPINAL SYSTEM; SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 1101-40001
Device Problem Unintended Movement (3026)
Patient Problem No Information (3190)
Event Date 06/14/2016
Event Type  Injury  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as no lot number has been identified/confirmed in this case.Since the occipital plate remains in the patient no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.During the revision, it was observed that the set screw and nut of the connector were loose.The implants were re-tightened during the revision.No definitive root cause can be determined.Device remains in patient.
 
Event Description
It was reported to k2m, inc.On (b)(6) 2016 that implants had loosened in an occipital bolt case post-op.Patient was revised on (b)(6) 2016.
 
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.It was reported that the patient heard a squeaking noise in his neck a few months post-op.During the first revision, it was observed that the set screw and nut of the connector were loose.The implants were re-tightened during this revision.During the second revision the implants were removed and the assembly swage of the anchor was compromised so the nut was separated from the rest of the anchor.Most of the damage observed on the anchor and threads is consistent with extrication.There is a significant abrasion on the bottom of the hook portion of the anchor.The abrasions on the rod and on the anchor with lot cyey are consistent with loading from a rod slip.No definitive root cause could be determined.Patient fall likely contributed to the loosening and dislocation of the nuts.The manufacturing and inspection records were reviewed and no discrepancies were found.
 
Event Description
It was reported to k2m, inc.On (b)(6) 2016 that implants had loosened in an occipital bolt case post-op.Patient was revised on (b)(6) 2016.Patient fell and was revised again on (b)(6) 2016.
 
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Brand Name
CASPIAN OCT SPINAL SYSTEM
Type of Device
SPINAL FIXATION SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer (Section G)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
sandra gilbert
600 hope parkway se
leesburg, VA 20175
5719192000
MDR Report Key5756182
MDR Text Key48399714
Report Number3004774118-2016-00042
Device Sequence Number1
Product Code NKG
UDI-Device Identifier10888857015876
UDI-Public10888857015876
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153370
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 06/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number1101-40001
Device Lot NumberCYEY
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/01/2016
Initial Date FDA Received06/28/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
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