Dsm13 4-0 Bl Ppn 18"/45cm J8699NRecalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · Dsm13 4-0 Bl Ppn 18"/45cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848782016815), received between Mar 4, 2024 and Dec 9, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Patient Device Interaction Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON 15 NOV 2024, IT WAS REPORTED THAT THE SURGEON HAD BEEN INFORMED OF APPROXIMATELY 1-4 CASES OF ERYTHEMA AROUND THE SURGICAL SITE SINCE (B)(6) 2024. ALL AFFECTED PATIENTS WERE TREATED WITH ANTIBIOTICS, AND NO SIGNS OF INFECTION WERE OBSERVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20879183 ↗MalfunctionMar 4, 2024Break; Break
THE NEEDLE TIP OF THE PRODUCT BROKE OFF AND WAS IN THE PATIENT¿S SURGICAL SITE. THE PATIENT WAS SENT TO THE HOSPITAL TO HAVE THE NEEDLE LOCATED SO THAT THE NEEDLE COULD BE REMOVED FROM THE SURGICAL SITE. NO PATIENT INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 18824104 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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