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: SPINAL KINETICS LLC M6-C; ARTIFICIAL CERVICAL DISC
  • 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
 

SPINAL KINETICS LLC M6-C; ARTIFICIAL CERVICAL DISC Back to Search Results
Model Number 6MM MEDIUM LONG
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 03/30/2019
Event Type  Injury  
Manufacturer Narrative
A review of the device history records for this device did not reveal any non-conformances.Additional information has been requested.
 
Event Description
It was reported that an m6-c artificial cervical disc that was implanted in 2017 was removed due to infection.
 
Manufacturer Narrative
G1: mr.(b)(6).G2: distributor/importer.G3: 20apr2021.Manufacturer narrative: it was reported that the patient revised due to infection.No radiographic images were provided and the lack of radiographic images hinders interpretation of surgical technique and/or patient selection.It was not possible to assess the potential role of surgical technique or patient selection based on the provided information.The implant was not intact as-received.The endplates were separated, the sheath was cleaved with a portion missing, multiple loose pieces of the fiber construct were detached from the endplates, and the core was damaged.No lab reports were provided, however, infection was reported.This device was likely intact at the time of removal, the device did not fail in vivo.Although radiographs, tissues, and lab results regarding the presence of infection were not provided, this device was likely removed due to the reported infection.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
M6-C
Type of Device
ARTIFICIAL CERVICAL DISC
Manufacturer (Section D)
SPINAL KINETICS LLC
501 mercury drive
sunnyvale CA 94085
MDR Report Key8580325
MDR Text Key144092087
Report Number3004987282-2019-00014
Device Sequence Number1
Product Code MJO
Combination Product (y/n)N
PMA/PMN Number
P170036
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/30/2021
Device Model Number6MM MEDIUM LONG
Device Catalogue NumberCDM-635L
Device Lot Number6663
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2019
Date Manufacturer Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-