Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M MESA MINI SPINAL SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

K2M MESA MINI SPINAL SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM Back to Search Results
Catalog Number 1101-03518F
Device Problems Material Fragmentation (1261); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 08/12/2019
Event Type  malfunction  
Manufacturer Narrative
The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, manufacturer will file a supplemental report indicating the findings.
 
Event Description
On (b)(6) 2019 it was reported to k2m, inc.That the outer collet of a screw was damaged during locking.The implant remains in the patient within the construct.
 
Manufacturer Narrative
The outer collet fragment was returned, visually and microscopically inspected.The surgeon was satisfied with the rest of the construct and decided not to replace the subject screw.Manufacturing and inspection records of the subject lot were reviewed and no relevant discrepancies were found.It is possible the locker was not properly aligned with the screw head, resulting in an unbalanced force that caused the outer collet to fracture.
 
Event Description
On (b)(6) 2019 it was reported to k2m, inc.That the outer collet of a screw was damaged during locking.The implant remains in the patient within the construct.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MESA MINI SPINAL SYSTEM
Type of Device
POSTERIOR CERVICAL SCREW SYSTEM
Manufacturer (Section D)
K2M
600 hope parkway se
leesburg VA 20175
MDR Report Key8716100
MDR Text Key148550299
Report Number3004774118-2019-00062
Device Sequence Number1
Product Code NKG
Combination Product (y/n)N
PMA/PMN Number
K153370
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1101-03518F
Device Lot NumberGCRJ-69815
Was Device Available for Evaluation? No
Date Manufacturer Received10/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-