Arthrex® AR-1588RT-IBRecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00888867291638), received between Jun 20, 2022 and May 12, 2026 — classified as 1 injury, 66 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT DURING THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT, THE LOOP ATTACHED TO THE GRAFT BROKE WHEN TENSION WAS APPLIED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148736 ↗
• MalfunctionMar 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE TIGHT ROPE TORE. PER COMPLAINT REPORTER, THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24667100 ↗
• MalfunctionMar 17, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE DEVICE TORE WHILE PULLIN THE CRUCIATE LIGAMENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621666 ↗
• MalfunctionFeb 20, 2026Break

  ON 04-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1588RT-IB TIGHTROPE II RT EXPERIENCED AN ISSUE DURING A PROCEDURE ON (B)(6) 2026. AFTER GRAFT PASSAGE, THE ADJUSTMENT LOOP WAS PULLED; HOWEVER, THE CHINESE FINGER TRAP MECHANISM BROKE, AND THE GRAFT DID NOT ADVANCE DESPITE ADDITIONAL TENSION. THE PROCEDURE MAY HAVE BEEN DELAYED BY MORE THAN AN HOUR, AND ADDITIONAL ANESTHESIA MAY HAVE BEEN REQUIRED. THE SURGERY WAS COMPLETED USING ANOTHER, UNSPECIFIED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 10-FEB-2026: THE AR-1588RT-IB TIGHTROPE II RT WAS REMOVED AFTER THE BREAK OCCURRED DURING THE ACL RECONSTRUCTION PROCEDURE, AND THE CASE WAS COMPLETED USING AN AR-1588BTB-IB TIGHTROPE II BTB. THE SURGERY WAS EXTENDED BY 45 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 24402267 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIGHTROPE SUTURE FAILED AT THE LOCKING MECHANISM. THE SUTURE LOOPS TIGHTENED FULLY AND THE CONNECTING SUTURE OVER THE BUTTON SNAPPED MEANING SUTURES WERE NO LONGER TENSIONED AGAINST THE BUTTON. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY BY USING A DIFFERENT TECHNIQUE: A FIXED LOOP FEMORAL FIXATION. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280626 ↗
• MalfunctionDec 17, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 18-DEC-2025: THIS WAS DISCOVERED DURING AN ACLR PROCEDURE. EVERYTHING WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-1588RT-IB TIGHTROPE II RT. THE SURGERY WAS DELAYED BY APPROXIMATELY 30 MINUTES TO REMOVE THE DEVICE, ASSESS THE ISSUE, AND REPLACE IT WITH A NEW IMPLANT. IT IS UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826393 ↗
• MalfunctionDec 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT QUADRICEPS / QUADLINK SURGERY; WHILE ATTEMPTING TO INSERT THE QUAD GRAFT FEMORAL, THE WHITE REDUCTION SUTURES WERE TORN OUT OF THE BUTTON AGAIN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741653 ↗
• MalfunctionDec 2, 2025Break; Break

  ON 11/12/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT THE SADDLE OF AN AR-1588RT-IB TIGHTROPE II RT HAD BROKEN DOWN, AND THE TIGHTROPE WAS NOT FUNCTIONING. THE SURGEON HAD TO TIE KNOTS ON THE FEMORAL SIDE TO SECURE IT AND COMPLETED THE CASE USING THE INITIAL TIGHTROPE BECAUSE THE SURGEON DID NOT WANT TO AND COULD NOT REMOVE THE ACL GRAFT FROM THE TUNNELS. THIS ISSUE WAS IDENTIFIED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/19/2025: THE TIGHTROPE IMPLANT BROKE AT THE SADDLE, CAUSING THE TIGHTENING SUTURES TO SLIDE FREELY BECAUSE THE MECHANISM WAS NO LONGER FUNCTIONAL. TO MAINTAIN CORTICAL FIXATION, THE SURGEON TIED MULTIPLE KNOTS ON THE BUTTON. NO ADDITIONAL PRODUCTS WERE USED, AND THE GRAFT COULD NOT BE REMOVED; THE SURGEON SECURED THE BUTTON WITH KNOTS INSTEAD. THE CASE WAS DELAYED BY A FEW MINUTES, AND IT IS UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. A FLIPCUTTER III WAS USED TO CREATE THE FEMORAL TUNNEL AND SOCKET, WHILE A FULL TIBIAL TUNNEL WAS PREPARED USING A NON-ARTHREX REAMER. THE PATIENT¿S BONE QUALITY WAS NORMAL, AND NO PHOTOS WERE TAKEN OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23695915 ↗
• MalfunctionNov 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556412 ↗
• MalfunctionNov 5, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588RT-IB TIGHTROPE® II RT BROKE IN HALF. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2025, WHEN THE SURGEON WAS ALMOST COMPLETE, THEY WENT TO PUT THE KNEE INTO FLEXION TO CYCLE THE KNEE, AND THEY HEARD A LOUD POP. THEY ALSO PERFORMED AN LET PROCEDURE, AND DURING THAT, IT WAS DISCOVERED THAT THE BONE CORTEX HAD NOT BEEN BROKEN, BUT THE BUTTON HAD COMPLETELY CRACKED IN HALF. AN X-RAY WAS TAKEN, AND IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. THE PATIENT HAD A HARD BONE QUALITY THAT WAS PREPPED USING A 4MM SPADE TIP DRILL AND A LOW-PROFILE REAMER. THERE WERE 45-50 MINUTES ADDED TO THE PROCEDURE. THE CASE WAS COMPLETED USING ANOTHER AR-1588RT-IB TIGHTROPE® II RT. THERE WAS NO HARM TO THE PATIENT'S BONE OR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478308 ↗
• MalfunctionNov 3, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588RT-IB, TIGHTROPE® II RT, RECONSTRUCTION WITH INTERNALBRACE¿ LIGAMENT AUGMENTATION REPAIR, IT FAILED AT THE SHEATH. THIS WAS DETECTED DURING AN ACL RECONSTRUCTION ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS BTB TIGHTROPES (AR-1588BTB-IB) WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 23451102 ↗
• MalfunctionNov 3, 2025Positioning Failure; Positioning Failure

  ON 29TH OCTOBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588RT-IB, TIGHTROPE® II RT, RECONSTRUCTION WITH INTERNALBRACE¿ LIGAMENT AUGMENTATION REPAIR, IT FAILED AT THE SHEATH. THIS WAS DETECTED DURING AN ACL RECONSTRUCTION ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS BTB TIGHTROPES (AR-1588BTB-IB) WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 23450851 ↗
• MalfunctionOct 15, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1588RT-IB TIGHTROPE II RT EXPERIENCED BREAKAGE. ONE SIDE OF THE GRAFT BROKE DURING THE SIXTH TENSIONING (FINAL PULL-UP TO THE TIP OF THE BONE TUNNEL) WHILE BEING PASSED THROUGH THE BONE TUNNEL. THE GRAFT WAS REMOVED FROM THE PATIENT, AND A REPLACEMENT AR-1588RT-IB TIGHTROPE II RT WAS USED TO COMPLETE THE SURGERY WITHOUT INCIDENT. THERE WAS NO SIGNIFICANT CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO SPECIFIC DETAILS REGARDING BONE PREPARATION OR BONE QUALITY WERE DOCUMENTED. NO PHOTOS WERE TAKEN OF THE EVENT, AND NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE SURGERY. THE EVENT OCCURRED DURING AN ACL RECONSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2025, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291816 ↗
• MalfunctionSep 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY THAT THE SUTURE BROKE DURING THE INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037538 ↗
• MalfunctionSep 2, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588RT-IB, TIGHTROPE® II RT, RECONSTRUCTION WITH INTERNALBRACE¿ LIGAMENT AUGMENTATION REPAIR, WHILE CINCHING GRAFT INTO FEMORAL TUNNEL, THE TIGHTROPE SNAPPED. THIS WAS DETECTED DURING USE IN A GRAFTLINK PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER TIGHTROPE WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 22940376 ↗
• MalfunctionAug 26, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1588RT-IB TIGHTROPE II RT EXPERIENCED A SUTURE BREAK WHEN PULLED UP INSIDE THE FEMUR. AS A RESULT, THE GRAFT WAS REMOVED FROM THE PATIENT, AND AN ALTERNATIVE AR-1588RT-IB TIGHTROPE II RT WAS USED TO COMPLETE THE PROCEDURE. THE CASE WAS EXTENDED BY MORE THAN AN HOUR, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED TO ACCOMMODATE THE DELAY. THIS ISSUE WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2025: DETAILS REGARDING BONE PREPARATION AND BONE QUALITY WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894935 ↗
• MalfunctionJul 22, 2025Break; Break

  ON 06/30/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1588RT-IB TIGHTROPE II RT, RECONSTRUCTION WITH INTERNALBRACE, HAD THE THREAD BREAK WHEN PASSING THROUGH THE BONE HOLE. ALL BROKEN PIECES WERE REMOVED. THE CASE WAS COMPLETED BY USING ANOTHER AR-1588RT-IB TIGHTROPE II-RT. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/08/2025: THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568682 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A PCL SURGERY THE DEVICE TORE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-1588RTT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414485 ↗
• MalfunctionJul 7, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE DEVICE TORE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414344 ↗
• MalfunctionJul 7, 2025Break; Break

  ON 6/10/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588RT-IB TIGHTROPE II RT HAD AN ISSUE DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON USED THE DEVICE, THE TIGHTROPE SUTURES BROKE INSIDE THE PATIENT AT FINAL TENSIONING. THE IMPLANT, TOGETHER WITH ALL SUTURES, WAS REMOVED FROM THE PATIENT, AND THERE WAS NO HARM. NOTHING OTHER THAN THE SUTURES HAD BROKEN. THE COMPLAINT DEVICE WAS AVAILABLE FOR RETURN. ANOTHER AR-1588RT-IB TIGHTROPE II RT WITH A DIFFERENT LOT NUMBER, 15304212, WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CASE WAS DELAYED FOR 20 MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414032 ↗
• MalfunctionJun 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PLASTIC SURGERY THE FEMORAL TIGHTROPE TORE WHILE IT WAS PULLED IN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298599 ↗
• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE THREAD BROKE DURING IMPLANT INSERTION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160423 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY WITH INTERNALBRACE LIGAMENT THE TIGHTROPE II RT SNAPPED WHEN THE SURGEON WENT TO RETENTION. HE THEN HAD TO REMOVE THE ENTIRE CONSTRUCT AND PLACE IN A NEW ONE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144421 ↗
• MalfunctionMay 27, 2025Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIGHTROPE FLIPPED BUT THE IMPLANT DID NOT TIGHTEN AND THE LOOPS OF THE FINGERTRAP KEPT COMING LOOSE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087981 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH TIGHTROPE RT II INTERNAL BRACE SURGERY THE SURGEON WAS SEQUENTIAL TENSIONING THE GRAFT INTO THE FEMUR SOCKET USING ARTERY CLIPS TO GRASP THE SUTURES. AS HE WAS BRINGING THE GRAFT INTO THE SOCKET THE TIGHTROPE SUDDENLY GAVE WAY. THE TIGHTROPE SNAPPED AT THE KNOTLESS MECHANISM. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063881 ↗