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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI
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CARTIVA, INC. CARTIVA SCI Back to Search Results
Model Number CAR-10-US
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Codes Pain (1994); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671)
Date of Event 11/09/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
According to the information provided by the involved surgeon, a patient received a cartiva mtp implant on (b)(6) 2018.Following, the patient underwent removal and revision to fusion on (b)(6) 2018 (approximately 2 months postoperative) after he complained of continued pain, swelling, and lack of mobility.The physician reported that the implant showed signs of fragmentation at the time of removal.
 
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Brand Name
CARTIVA SCI
Common Device Name
CARTIVA SCI
Manufacturer (Section D)
CARTIVA, INC.
6120 windward parkway
suite 220
alpharetta GA 30005
MDR Report Key8160397
Report Number3009351194-2018-00012
Device Sequence Number12590034
Product Code PNW
UDI-Device Identifier00852897002038
UDI-Public(01)00852897002038(10)F032218001(17)2020-04-30
Combination Product (Y/N)N
PMA/510(K) Number
P150017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Type of Report Initial
Report Date (Section B) 12/13/2018
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
Operator of Device Health Professional
Device Expiration Date04/30/2020
Device Model NumberCAR-10-US
Device Catalogue NumberCAR-10-US
Device Lot NumberF032218001
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2018
Initial Report FDA Received Date12/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age38 YR
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