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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. ALEUTIAN INTERBODY SYSTEMS; INTERVERTEBRAL BODY FUSION DEVICE
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K2M, INC. ALEUTIAN INTERBODY SYSTEMS; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number 603-20928C
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 10/05/2017
Event Type  malfunction  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
 
Event Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible interbody migration approximately 3 months post-op.There are no plans to revise at this time.The patient is asymptomatic.
 
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 was completed as the lot number has been identified/confirmed in this case.Since the interbody remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.Osteolysis may have contributed to the migration.
 
Event Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible interbody migration approximately 3 months post-op.There are no plans to revise at this time.The patient is asymptomatic.
 
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Brand Name
ALEUTIAN INTERBODY SYSTEMS
Type of Device
INTERVERTEBRAL BODY FUSION DEVICE
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
5719192195
MDR Report Key6998580
MDR Text Key92059358
Report Number3004774118-2017-00167
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110843
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 10/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number603-20928C
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/05/2017
Initial Date FDA Received11/03/2017
Supplement Dates Manufacturer Received10/05/2017
Supplement Dates FDA Received11/30/2017
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
Patient Age76 YR
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