• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

  • 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
 

CARTIVA, INC. CARTIVA SCI Back to Search Results
Model Number CAR-10-US
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)
Event Date 07/16/2019
Event Type  Injury  
Manufacturer Narrative
A review of the quality and manufacturing records for the product lot was conducted and found that the product met all the predefined acceptance criteria for final release.All sterilization records demonstrate the appropriate dose was applied, and all sterilization specifications were met.As the implant was not returned, an assessment of the device could not be carried out.Likewise, additional information regarding the patient's current clinical course was not made available at the time of this report.With the information provided, no definitive root cause could be determined for this event.If additional information is received in the future, this file will be re-opened for assessment/ investigation and updated accordingly.
 
Event Description
Surgeon feedback received via email communication.The physician reported a cartiva device being implanted on a patient on (b)(6) 2019.Following, a staphylococcus of undetermined origin was found present in the operated area, and the device was removed on (b)(6) 2019.Per the information provided, the patient was treated with a washout and antibiotic cement but has not received a revision.At the present time, no additional information about the patient's current clinical course was made available.
 
Event Description
Surgeon feedback received via email communication.The physician reported a cartiva device being implanted in a patient on (b)(6) 2019.Following, a staphylococcus infection of undetermined origin was found present in the operated area, and the device was removed on (b)(6) 2019.Per the information provided, the patient was treated with a washout and antibiotic cement but has not received a revision.At the present time, no additional information about the patient's current clinical course was made available.
 
Manufacturer Narrative
This submission report corrects original patient code and provides additional information for cartiva complaint 19-063, reported on 13-aug-2019 under report number 3009351194-2019-00014.The device was returned for assessment after initial 30-day report.A visual examination of the device returned to cartiva was carried out.The articulating surface of the device exhibited scuffing and smooth, indented areas of wear across the top surface and around the perimeter of the device.The lateral walls of the device exhibited minor scratching.The bottom edge of the device was rough in appearance, with more substantial wear and tags of material present on one half of the perimeter.The device's maximum diameter and height, and weight, were found within the post-sterilization value ranges established through validation of the manufacturing process.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARTIVA SCI
Type of Device
CARTIVA SCI
Manufacturer (Section D)
CARTIVA, INC.
6120 windward parkway
suite 220
alpharetta GA 30005
MDR Report Key8889564
MDR Text Key154259506
Report Number3009351194-2019-00014
Device Sequence Number1
Product Code PNW
UDI-Device Identifier00852897002038
UDI-Public(01)00852897002038(10)F062818001(17)2020-07-31
Combination Product (y/n)N
PMA/PMN Number
P150017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Expiration Date07/31/2020
Device Model NumberCAR-10-US
Device Catalogue NumberCAR-10-US
Device Lot NumberF062818001
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/15/2019
Initial Date FDA Received08/13/2019
Supplement Dates Manufacturer Received07/15/2019
Supplement Dates FDA Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-