LATERA LATANI02Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00857037006044), received between Mar 30, 2017 and Feb 26, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expulsion” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2024Fracture; Expulsion; Fracture; Expulsion

  THE PATIENT REPORTED THAT ON (B)(6) 2022, THEY UNDERWENT A VISION SEPTOPLASTY, BILATERAL NASAL VALVE RECONSTRUCTION AND A LATERA IMPLANTATION. FOUR MONTHS POST-OP THE PATIENT REPORTED FACIAL DISCOMFORT, HEADACHES AND MIGRAINES. A BROWN SPOT PRESENTED ON THE NOSE WHICH WAS PAINFUL. THE SPOT TURNED INTO AN INFLECTIONAL SPOT AND ON (B)(6), 2023 A SMALL PIECE OF THE IMPLANT CAME THROUGH THE SKIN IN THE BROWN SPOT THAT HAD FORMED. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE INITIAL REPORTER.

  Patient problems: Pain; Skin Discoloration

  MAUDE report 18781843 ↗
• InjuryOct 12, 2023Fracture; Expulsion; Fracture; Expulsion

  THE USER FACILITY REPORTED THAT THE PATIENT PRESENTED 2 WEEKS POST-OP WITH AN EXTRUSION OF A FRACTURED PIECE OF THE NASAL IMPLANT. THE PIECE THAT WAS EXTRUDED WAS REMOVED DURING AN ADDITIONAL PROCEDURE. THE OTHER PIECE REMAINS IN THE PATIENT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17926798 ↗
• MalfunctionOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE PATIENT PRESENTED SEVERAL MONTHS POST-OP WITH PAIN AND TENDERNESS AT THE CEPHALIC ENDS OF THE IMPLANTS. THE PATIENT REPORTED THAT THEY NEEDED NEW GLASSES. AFTER THE FOLLOW-UP APPOINTMENT THE SURGEON DID NOT FEEL THAT THE SYMPTOMS WERE BEING CAUSED BY THE IMPLANT ¿ THE SURGEON OFFERED TO ADMINISTER SOME STEROID INJECTIONS AT THE SITE OF PAIN. THE PATIENT REFUSED THE STEROID INJECTION AS TREATMENT AND WAS SATISFIED WITH THE DOCTORS REPORT. NO ADDITIONAL SURGERY WAS PERFORMED, NO ADDITIONAL MEDICAL INTERVENTION WAS GIVEN AS A RESULT OF THE EVENT.

  Patient problems: Pain

  MAUDE report 17926255 ↗
• InjurySep 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THREE YEARS POST IMPLANT THE LATERA DEVICE IS PROTRUDING OUT THE SIDE OF THE PATIENT'S NOSE CAUSING PAIN AND DISFIGUREMENT.

  Patient problems: Pain

  MAUDE report 10554253 ↗
• InjuryAug 3, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT APPROXIMATELY TWO (2) DAYS POST BILATERAL LATERAL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PAIN AND YELLOW AND GREEN PUS ON THE RIGHT SIDE OF THE NOSE AND SWELLING AND REDNESS ON THE LEFT SIDE, COINCIDENT WITH THE IMPLANTS. IT WAS ALSO REPORTED THAT THE PHYSICIAN PRESCRIBED AUGMENTIN AND REMOVED THE IMPLANT ON THE RIGHT SIDE THROUGH THE ORIGINAL IMPLANTATION PIERCE POINT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT; NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7748064 ↗
• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED APPROXIMATELY SIX (6) WEEKS AFTER A BILATERAL IMPLANT PROCEDURE WITH AN ABSCESS ALONG THE LEFT LATERAL NASAL WALL COINCIDENT WITH THE FORKS OF THE LATERA ABSORBABLE NASAL IMPLANT. NO PROBLEMS WERE REPORTED ON EITHER SIDE OF THE NOSE DURING THE TWO-WEEK POST IMPLANTATION FOLLOW-UP VISIT OR ON THE RIGHT SIDE OF THE NOSE AT SIX (6) WEEKS POST IMPLANTATION. THE PHYSICIAN INCISED AND DRAINED THE ABSCESS AND PACKED THE WOUND, WITH THE IMPLANT IN SITU. WHEN THE PHYSICIAN REMOVED THE PACKING THE IMPLANT FORKS CAME OUT WITH THE PACKING MATERIAL. AT APPROXIMATELY EIGHT (8) WEEKS POST IMPLANTATION THE PATIENT RETURNED FOR FOLLOW UP WITH SOME SWELLING. THE PHYSICIAN REMOVED THE REMAINDER OF THE IMPLANT, WHICH HAD MIGRATED SUPERIORLY.

  Patient problems: Abscess

  MAUDE report 7146705 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED APPROXIMATELY TEN (10) DAYS AFTER A BILATERAL IMPLANT PROCEDURE WITH DRAINAGE, TENDERNESS AND REDNESS ALONG THE LATERAL NASAL WALL COINCIDENT WITH THE LATERA ABSORBABLE NASAL IMPLANT ON THE LEFT SIDE. NO PROBLEMS WERE REPORTED ON THE RIGHT SIDE OF THE NOSE. THE PHYSICIAN PRESCRIBED ANTIBIOTICS FOR 14 DAYS WITH MINIMAL IMPROVEMENT AND NOTED AN ACTIVE INFECTION IN THE LEFT SIDE WALL OF THE NOSE. THE IMPLANT ON THE LEFT SIDE WAS SURGICALLY REMOVED IN TWO PIECES USING A POCKET INCISION STARTING AT THE ALAR RIM ADVANCING TO THE ALAR CREASE. THE INCISION WAS CLOSED WITH A SUTURE. IT WAS REPORTED AT APPROXIMATELY TWO WEEKS AFTER IMPLANT REMOVAL THAT THE INFECTION RESOLVED WITH NO FURTHER SEQUELAE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7068550 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON(B)(6) 2017 THAT A PATIENT PRESENTED APPROXIMATELY ONE (1) WEEK AFTER A BILATERAL IMPLANT PROCEDURE WITH REDNESS ALONG THE LATERAL NASAL WALL COINCIDENT WITH THE LATERA ABSORBABLE NASAL IMPLANT. THE ACTUAL DATE OF THE IMPLANT PROCEDURE IS UNKNOWN. THE PHYSICIAN PRESCRIBED ANTIBIOTICS. AFTER APPROXIMATELY ANOTHER WEEK, THE REDNESS DID NOT DIMINISH AND THE IMPLANT WAS EXPOSED THROUGH THE EXTERNAL SKIN. THE PHYSICIAN SUSPECTED COLONIZED (B)(6) AND SURGICALLY REMOVED THE IMPLANT AND THE INFECTION RESOLVED. NO ISSUES WERE NOTED ON THE CONTRALATERAL SIDE WHERE A LATERA IMPLANT WAS ALSO PLACED.

  Patient problems: Staphylococcus Aureus; Unspecified Infection

  MAUDE report 6877325 ↗
• InjuryJul 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LATERA ABSORBABLE NASAL IMPLANT PROCEDURE AND THEN, ABOUT 6 MONTHS POST-PROCEDURE PRESENTED WITH REDNESS AND SWELLING ALONG THE AREA OF THE IMPLANT AND AN ULCER ON THE AREA OVER THE LOWER LATERAL CARTILAGE ON ONE SIDE. THE IMPLANT WAS SUSPECTED TO BE 'POKING' ALMOST THROUGH THE LOWER LATERAL CARTILAGE. SURGICAL REMOVAL OF THE INFECTED IMPLANT WAS ATTEMPTED UNSUCCESSFULLY AS IT WAS DIFFICULT TO FEEL THE LOCATION OF THE IMPLANT. TOPICAL AND SYSTEMIC STEROIDS WERE PRESCRIBED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME REGARDING PATIENT STATUS.

  Patient problems: Swelling; Ulcer; Unspecified Infection

  MAUDE report 6732381 ↗
• InjuryJun 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL LATERA ABSORBABLE NASAL IMPLANT PROCEDURE AND THEN, ABOUT THREE WEEKS LATER PRESENTED WITH REDNESS AND SWELLING ON THE RIGHT SIDE. TOPICAL AND SYSTEMIC (ORAL) ANTIBIOTICS WERE PRESCRIBED. THE CONDITION WAS NOTED TO BE IMPROVED AT THE FOLLOW UP VISIT APPROXIMATELY TWO WEEKS LATER. A FOLLOW-UP REPORT INDICATED THAT THE PATIENT'S CONDITION HAD WORSENED AT TWO MONTHS AFTER IMPLANT, WITH PUS SEEPING FROM THE IMPLANT AREA ON THE RIGHT SIDE. THE IMPLANT ON THE PATIENT'S RIGHT SIDE WAS SURGICALLY REMOVED APPROXIMATELY TWO MONTHS POST IMPLANTATION TO ADDRESS THE INFECTION. THE INFECTION RESOLVED AND THE IMPLANT ON THE LEFT SIDE REMAINS IMPLANTED.

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 6645613 ↗
• InjuryApr 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL LATERA ABSORBABLE NASAL IMPLANT PROCEDURE AND ABOUT TWO WEEKS LATER PRESENTED WITH PAIN, REDNESS, AND SWELLING ON THE RIGHT SIDE. AUGMENTIN WAS PRESCRIBED FOR THE INFECTION AND WAS CHANGED TO CLINDAMYCIN DUE TO GI UPSET. THE INFECTION DID NOT RESOLVE AFTER A WEEK OF ANTIBIOTICS AND THE PATIENT CONTINUED TO COMPLAIN ABOUT PAIN, BUT NO OTHER CONSTITUTIONAL SYMPTOMS (FEVER, ETC.) WERE REPORTED. STRONGER ANTIBIOTICS WERE NOT PRESCRIBED; THE DISTAL SEGMENT OF THE IMPLANT WAS SURGICALLY REMOVED TO ADDRESS THE INFECTION. THE PROXIMAL SEGMENT COULD NOT BE REMOVED AND WAS LEFT IN PLACE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME REGARDING PATIENT STATUS.

  Patient problems: Pain; Swelling; Unspecified Infection

  MAUDE report 6505600 ↗
• InjuryMar 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF A FULLNESS / SENSITIVITY BETWEEN THE INNER CANTHUS AND RADIX OF THE EYE AT THE LOCATION OF THE IMPLANT DISTAL FORKS. THE PATIENT ALSO COMPLAINED OF MINOR INFLAMMATION AT THIS SITE CAUSING SOME AESTHETIC IMPACT. NO OTHER EYE RELATED ISSUES WERE RECORDED BY THE PHYSICIAN. THIS WAS REPORTED IN FULL APPROXIMATELY 2 WEEKS AFTER IMPLANTATION. THE PHYSICIAN SUGGESTED WAITING 2 WEEKS TO EVALUATE THE MINOR AESTHETIC CONCERNS AND SENSITIVITY THAT IS TYPICAL OF PROCEDURES SUCH AS THIS AND RESOLVES WITHIN 4-6 WEEKS. NO SIGNS OF INFECTION WERE REPORTED AND NO ANTIBIOTICS WERE GIVEN PROPHYLACTICALLY. TWO WEEKS LATER, THE PHYSICIAN REPORTED THAT THE IMPLANT WAS SURGICALLY REMOVED IN THE CLINIC AT THE PATIENT'S REQUEST BASED ON HER CONTINUED DISCOMFORT. ANY AESTHETIC CONCERNS HAD RESOLVED COMPLETELY. THE IMPLANT WAS FULLY INTACT DURING THE FIRST ATTEMPTED REMOVAL. THE PHYSICIAN INJECTED LOCAL ANESTHETIC IN THE LATERAL WALL AND MADE A VERY SMALL INTERNAL MARGINAL INCISION AT THE CAUDAL EDGE OF THE LOWER LATERAL CARTILAGE AND DISSECTED A SMALL POCKET IN THE LATERAL WALL WITH MOSQUITO FORCEPS IN A CONVENTIONAL MANNER. HE WAS UNABLE TO LOCATE AND RETRIEVE

  Patient problems: Pain

  MAUDE report 6447322 ↗