FDA Adverse Event
Injury
Summary report: N
CARTIVA SCI IMPLANT FOR MTP
MDR report key: 13606475
·
Received February 25, 2022
Report
- Report Number
- 3009351194-2022-00048
- Event Type
- Injury
- Date Received
- February 25, 2022
- Date of Event
- April 17, 2018
- Report Date
- June 11, 2019
- Manufacturer
- CARTIVA, INC
- Product Code
- PNW
- PMA / PMN Number
- P150017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. MEDWATCH SUBMITTED: MW5086961. ON NOVEMBER 10, 2020 STRYKER TRAUMA AND EXTREMITIES ACQUIRED CARTIVA, WRIGHT MEDICAL, TORNIER INC. AND TORNIER (B)(4). AN EFFORT WAS MADE TO ALIGN THE ACQUIRED ENTITY COMPLAINT FILES WITH STRYKER'S POLICIES AND PROCEDURES. STRYKER HAS PERFORMED RETROSPECTIVE REVIEW OF COMPLAINTS AND THE REPORTABILITY DECISION WAS REVISED TO REPORT THIS INCIDENT UNDER THE MDR/VIGILANCE PROCESS.
Description of Event or Problem · 0
MEDWATCH REPORT RECEIVED STATED IN EVENT DESCRIPTION: "REVISION OF APPROVED IMPLANT THAT WAS SIGNIFICANTLY DAMAGED AND HAD DECREASED IN SIZE SINCE INITIAL IMPLANTATION." "IMPLANT DURATION REPORTED AS 18 MONTHS". REFER TO MEDWATCH MW5086961.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1680611 | CARTIVA SCI IMPLANT FOR MTP | METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT PROSTHESIS, | PNW | CARTIVA, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |