PreservaRidge™ Plug PRPSLMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10813954024544), received between Nov 10, 2023 and Nov 10, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain

  MAUDE report 18116138 ↗
• InjuryNov 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain

  MAUDE report 18116136 ↗