PRESERVARIDGE PLUG
Report
- Report Number
- 2249852-2023-00020
- Event Type
- Injury
- Date Received
- November 10, 2023
- Date of Event
- June 1, 2023
- Report Date
- January 31, 2024
- Manufacturer
- COLLAGEN MATRIX, INC.
- Product Code
- NPM
- UDI-DI
- 00813954024400
- PMA / PMN Number
- K083742
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL QUALITY CONTROL TESTING OF RESERVE PRODUCT AND PRODUCT FROM THE SAME LOT RETURNED BY THE DISTRIBUTOR WERE TESTING FOR STERILITY. THE PRODUCT WAS PROVEN TO BE STERILE. THIS MDR (2249852-2023-00020 SUPPLEMENT 1) IS FOR SUSPECT DEVICE 1 OF 5 AND IS A SUPPLEMENT TO THE PARENT MDR (2249852-2023-00020). PLEASE REFER TO MDR NUMBERS 2249852-2023-00022 (AND 2249852-2023-00022 SUPPLEMENT 1), 2249852-2023-00023 (AND 2249852-2023-00023 SUPPLEMENT 1), 2249852-2023-00024 (AND 2249852-2023-00024 SUPPLEMENT 1) AND 2249852-2023-00025 (AND SUPPLEMENT 2249852-2023-00025 SUPPLEMENT 1) FOR THE OTHER REPORTED SUSPECT DEVICES. NO INITIAL REPORTER INFORMATION WAS PROVIDED. COMPLAINT WAS REPORTED TO MANUFACTURER BY DISTRIBUTOR. REPORTER INFORMATION WAS REQUESTED BUT NOT PROVIDED. ADDITIONAL INFORMATION AND CLARIFICATION WAS REQUESTED, INCLUDING: WHAT DEVICE WAS UTILIZED ON WHAT PATIENT, THE EXACT NUMBER OF PATIENTS AFFECTED, IF THERE WAS ANY SURGICAL DELAY, INFORMATION RELATED TO THE REPORTED EVENT, CURRENT PATIENT STATUS, AND CLARIFICATION ON PRODUCT INFORMATION PER PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER MULTIPLE FOLLOW-UPS. THERE ARE TWO PRODUCT CODES ASSOCIATED WITH THIS DEVICE: LYC AND NPM. SECTION D2 LISTS CODE NPM. FOR PRODUCT CODE LYC: PRODUCT CODE NAME: BONE GRAFTING MATERIAL, SYNTHETIC. DEVICE CLASS: CLASS II. CLASSIFICATION PANEL: 76-DENTAL. C.F.R. SECTION: 872.3930-BONE GRAFTING MATERIAL.
INVESTIGATION IS ONGOING. ADDITIONAL QUALITY CONTROL RESULTS ARE PENDING. THIS MDR IS FOR SUSPECT DEVICE 1 AND THE PARENT MDR. PLEASE REFER TO MDR NUMBERS 2249852-2023-00022, 2249852-2023-00023, 2249852-2023-00024 AND 2249852-2023-00025 FOR THE OTHER REPORTED SUSPECT DEVICES. NO INITIAL REPORTER INFORMATION WAS PROVIDED. COMPLAINT WAS REPORTED TO MANUFACTURER BY DISTRIBUTOR. REPORTER INFORMATION WAS REQUESTED BUT NOT PROVIDED. ADDITIONAL INFORMATION AND CLARIFICATION WAS REQUESTED, INCLUDING: WHAT DEVICE WAS UTILIZED ON WHAT PATIENT, THE EXACT NUMBER OF PATIENTS AFFECTED, IF THERE WAS ANY SURGICAL DELAY, INFORMATION RELATED TO THE REPORTED EVENT, CURRENT PATIENT STATUS, AND CLARIFICATION ON PRODUCT INFORMATION PER PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER MULTIPLE FOLLOW-UPS. THERE ARE TWO PRODUCT CODES ASSOCIATED WITH THIS DEVICE: LYC AND NPM. SECTION D2 LISTS CODE NPM. FOR PRODUCT CODE LYC: PRODUCT CODE NAME: BONE GRAFTING MATERIAL, SYNTHETIC DEVICE CLASS: CLASS II CLASSIFICATION PANEL: 76-DENTAL C.F.R. SECTION: 872.3930-BONE GRAFTING MATERIAL.
LIMITED INFORMATION WAS PROVIDED. IT WAS REPORTED THAT "SEVERAL PATIENTS" NEEDED TO HAVE THE PRESERVARIDGE PLUGS REMOVED AND REDRAFTED. ALL PATIENTS EXPERIENCED PAIN AND SWELLING AT THE GRAFT SITE. MULTIPLE ITEM NUMBERS AND MULTIPLE LOT NUMBERS FOR THE EVENT WERE PROVIDED, HOWEVER IT WAS NOT SPECIFIED WHAT SPECIFIC DEVICE WAS UTILIZED ON EACH PATIENT. ONLY ONE EVENT DATE FOR THIS ISSUE. ADDITIONAL INFORMATION AND CLARIFICATION WAS REQUESTED, INCLUDING: THE EXACT NUMBER OF PATIENTS AFFECTED, IF THERE WAS ANY SURGICAL DELAY, INFORMATION RELATED TO THE REPORTED EVENT, CURRENT PATIENT STATUS, AND CLARIFICATION ON PRODUCT INFORMATION PER PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER MULTIPLE FOLLOW-UPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2161550 | PRESERVARIDGE PLUG | SYNOSS COLLAGEN SYNTHETHIC MINERAL - COLLAGEN BONE GRAFT MATRIX | NPM | COLLAGEN MATRIX, INC. | PRPREG | SMCPN220802 | 00813954024400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |