PRIMATRIX 18 MM DISC
Report
- Report Number
- 3004170064-2024-00001
- Event Type
- Injury
- Date Received
- January 17, 2024
- Date of Event
- November 24, 2021
- Report Date
- June 17, 2024
- Manufacturer
- TEI BIOSCIENCES INC
- Product Code
- KGN
- PMA / PMN Number
- K153690
- Removal / Correction Number
- 3004170064-05/23/2023-00
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
UPDATED FIELDS: H11. THE PRIMATRIX (ID 607-005-018) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
ADDITIONAL INFORMATION RECEIVED: QUESTION: FOR OUR DOCUMENTATION, CAN YOU PLEASE ADVISE WHY THERE WAS A DELAY IN SUBMITTING THE MEDWATCH FORMS FOR THE VARIOUS PRIMATRIX COMPLAINTS REPORTED IN NOVEMBER OF 2023. SOME COMPLAINTS DATE BACK AS FAR AS 2019, BUT ALL COMPLAINTS WERE REPORTED AT THE SAME TIME IN NOVEMBER 2023. WAS THIS DUE TO THE RECALL? ANSWER: "YES. THIS WAS DUE TO THE INTEGRA RECALL." FDA RECALL NUMBER: RES# 92481.
ADDITIONAL INFORMATION RECEIVED: QUESTION: FOR OUR DOCUMENTATION, CAN YOU PLEASE ADVISE WHY THERE WAS A DELAY IN SUBMITTING THE MEDWATCH FORMS FOR THE VARIOUS PRIMATRIX COMPLAINTS REPORTED IN NOVEMBER OF 2023. SOME COMPLAINTS DATE BACK AS FAR AS 2019, BUT ALL COMPLAINTS WERE REPORTED AT THE SAME TIME IN NOVEMBER 2023. WAS THIS DUE TO THE RECALL? ANSWER: "YES. THIS WAS DUE TO THE INTEGRA RECALL." - FDA RECALL NUMBER: RES# 92481.
MEDWATCH: MW5148711. A FACILITY REPORTED: "LEFT PLANTAR FOOT - 5TH MTP AREA- FULL THICKNESS ULCERATION WITH PALE PINK WOUND BED. NO SIGN OF INFECTION. GRANULATION TISSUE IS PRESENT BUT IS FLAT. 11/24- LAST WEEK WE PLACED PRIMATRIX # 1. TODAY HE PRESENTS HAVING INCREASED DRAINAGE FROM THE SITE. THE WOUND MEASURES SL INCREASED IN SIZE AND DEPTH. WOUND BASE IS RED AND GRANULAR. PLAN TODAY TO START DOXY, GET CULTURE. WILL USE IODOFLEX THIS WEEK AND WILL PLAN TO HOLD ON PLACEMENT OF GRAFT FOR NOW." ADDITIONAL INFORMATION RECEIVED: - THE INITIAL PRIMATRIX WAS APPLIED ON 11/18/2021. - GRAFT SIZE: 18 MM. - GRAFT LOT#: 2102006. - EXPIRATION DATE: 07/31/2025. - SALINE LOT#: 1203810. - EXPIRATION DATE: 3/30/24. - TOTAL AMOUNT OF GRAFT USED: 100 %. - TOTAL AMOUNT OF GRAFT WASTED: 0 %. - PATIENT AGE AND GENDER: PATIENT ¿ NON HISPANIC, CAUCASIAN , 75 Y/O MALE.
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1602211 | PRIMATRIX 18 MM DISC | PRIMATRIX | KGN | TEI BIOSCIENCES INC | 2102006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | SALINE LOT#:1203810, EXPIRATION DATE: 3/30/24 |