PERLA TLRecalls & reported problems across all models
SpineArt SA · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PERLA TL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 11 models of PERLA TL by SpineArt SA in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, 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).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PERLA TL recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 15, 2024Open, Classified
Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew
Z-1758-2024 · Root cause: Process design · names 10 of these models · Recall details · FDA record ↗
Most reported PERLA TL problems
Device problems
- Contamination /Decontamination Problem2
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
PERLA TL models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PERLA ® TL TLF-DS 45 25-SAppliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 45 30-SAppliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 45 35-SAppliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 45 40-SAppliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 45 45-SAppliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 55 30-SAppliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 55 35-SAppliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 55 40-SAppliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 55 45-SAppliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-DS 60 35-SAppliance, Fixation, Spinal Interlaminal1 recall0 reports
- PERLA ® TL TLF-IN 05 41-NScrewdriver2 reports
Recent PERLA TL adverse event reports
The 2 most recent reports across all models, 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 ↗
Other SpineArt SA products
All SpineArt SA devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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