PERLA ® TL TLF-IN 05 41-NRecalls & reported problems
SpineArt SA · FINAL TIGHTENER · Class 1
All models of PERLA TL (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640450868954), received between Mar 27, 2024 and Nov 1, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. 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
- Contamination /Decontamination Problem2
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
ON 10.OCT.2024, WE RECEIVED A COMPLAINT FROM FRANCE REGISTERED UNDER CPT-3260, REPORTING THAT DURING A SURGERY ON (B)(6) 2024, WHEN USING THE FINAL TIGHTENER INSTRUMENT REFERENCE TLF-IN 05 41-N, BATCH NUMBER 6-8534/001, WATER LEAKED INTO THE PATIENT. THE SURGEON COMPLETED THE SURGERY BY USING ANOTHER INSTRUMENT. THE SURGICAL SITE WAS WASHED WITH BETADINE SERUM (THE PATIENT IS UNDER SYSTEMATIC PREOPERATIVE ANTIBIOTIC TREATMENT). THE PATIENT IS FINE AND HE LEFT THE HOSPITAL WITH NO PROLONGED HOSPITALIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20586640 ↗MalfunctionMar 27, 2024Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material
ON (B)(6) 2024, WE RECEIVED A COMPLAINT FROM SPAIN, REGISTERED UNDER CPT-2883, REPORTING THAT DURING A SURGERY ON (B)(6) 2024, WHEN USING THE FINAL TIGHTENER INSTRUMENT REFERENCE TLF-IN 05 41-N, BATCH NUMBER 6-9649/051, BROWN WATER LEAKED INTO THE SURGICAL SITE.HIGH RISK OF INFECTION REPORTED.THE EVENT IS REPORTED TO FDA BECAUSE THIS INSTRUMENT IS USED IN THE US MARKET. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT TO PREVENT ANY POTENTIAL INFECTION. NO FURTHER COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 18986110 ↗
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- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
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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