TRANSLACE™ Spinal Tethering System 8219500 (UDI 00763000108397)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000108397), received between Oct 23, 2019 and Mar 3, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE T2-L2 POSTERIOR FUSION FOR SCOLIOSIS. IT WAS REPORTED THAT PRODUCT SHEARED AND SNAPPED WHEN THE TENCHENER WAS APPLIED.NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT CONNECTOR PERFORMED AS EXPECTED, NO ISSUES WITH THE CONNECTOR. NO REVISION SURGERY PLANNED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502660 ↗
• MalfunctionMay 13, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SCOLIOSIS; AND UNDERWENT A CORRECTION SURGERY AT T6-L3. INTRA-OP, AFTER PLACEMENT WAS PERFORMED, THE TETHERS BROKE WHILE APPLYING TENSION WITH THE TENSIONER. TENSION WAS APPLIED WHEN CORRECTION WAS ONCE PERFORMED. AFTER PROVISIONAL FIXATION, LOOSENING WAS PERFORMED. AND WHEN TENSION WAS APPLIED AGAIN DURING THE SECOND CORRECTION, THE TETHERS BROKE. THEREFORE, PRODUCT FROM ANOTHER MANUFACTURER (NESPLON) WAS USED. THE SURGEON WONDERED WHETHER CORRECTION WAS PERFORMED EXCESSIVELY. THE BROKEN PRODUCT WAS REMOVED WITH NO FRAGMENT OF THE PRODUCT REMAINING INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10052258 ↗
• MalfunctionMay 13, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SCOLIOSIS; AND UNDERWENT A CORRECTION SURGERY AT T6-L3. INTRA-OP, AFTER PLACEMENT WAS PERFORMED, THE TETHERS BROKE WHILE APPLYING TENSION WITH THE TENSIONER. TENSION WAS APPLIED WHEN CORRECTION WAS ONCE PERFORMED. AFTER PROVISIONAL FIXATION, LOOSENING WAS PERFORMED. AND WHEN TENSION WAS APPLIED AGAIN DURING THE SECOND CORRECTION, THE TETHERS BROKE. THEREFORE, PRODUCT FROM ANOTHER MANUFACTURER (NESPLON) WAS USED. THE SURGEON WONDERED WHETHER CORRECTION WAS PERFORMED EXCESSIVELY. THE BROKEN PRODUCT WAS REMOVED WITH NO FRAGMENT OF THE PRODUCT REMAINING INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10052243 ↗
• MalfunctionDec 6, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SCOLIOSIS; AND UNDERWENT SPINAL FUSION, SAGITTAL RE-ALIGNMENT AND DEROTATION. INTRA-OP, DURING CURVE CORRECTION, WHILE TENSIONING THE TETHER, THE INSTRUMENT STARTED DAMAGING THE TISSUE OF THE TETHER; HENCE, THE PHYSICIAN HAD TO STOP APPLYING TENSION. THEN, THE DAMAGED DISTAL PART OF THE TETHER WAS CUT AND REMOVED. THE BROKEN PART DID NOT REMAIN INSIDE THE PATIENT. REPORTEDLY, A VERY GOOD CORRECTION OF THE SCOLIOTIC CURVE COULD NOT BE PERFORMED DUE TO THIS EVENT; HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9429403 ↗
• MalfunctionDec 6, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SCOLIOSIS; AND UNDERWENT SPINAL FUSION, SAGITTAL RE-ALIGNMENT AND DEROTATION. INTRA-OP, DURING CURVE CORRECTION, WHILE TENSIONING THE TETHER, THE INSTRUMENT STARTED DAMAGING THE TISSUE OF THE TETHER; HENCE, THE PHYSICIAN HAD TO STOP APPLYING TENSION. THEN, THE DAMAGED DISTAL PART OF THE TETHER WAS CUT AND REMOVED. THE BROKEN PART DID NOT REMAIN INSIDE THE PATIENT. REPORTEDLY, A VERY GOOD CORRECTION OF THE SCOLIOTIC CURVE COULD NOT BE PERFORMED DUE TO THIS EVENT; HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9429319 ↗
• MalfunctionDec 6, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SCOLIOSIS; AND UNDERWENT SPINAL FUSION, SAGITTAL RE-ALIGNMENT AND DEROTATION. INTRA-OP, DURING CURVE CORRECTION, WHILE TENSIONING THE TETHER, THE INSTRUMENT STARTED DAMAGING THE TISSUE OF THE TETHER; HENCE, THE PHYSICIAN HAD TO STOP APPLYING TENSION. THEN, THE DAMAGED DISTAL PART OF THE TETHER WAS CUT AND REMOVED. THE BROKEN PART DID NOT REMAIN INSIDE THE PATIENT. REPORTEDLY, A VERY GOOD CORRECTION OF THE SCOLIOTIC CURVE COULD NOT BE PERFORMED DUE TO THIS EVENT; HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9428825 ↗
• MalfunctionNov 8, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOTIC CURVE CORRECTION AFTER SHE WAS DIAGNOSED WITH SCOLIOSIS. INTRA-OP, WHEN THE SURGEON PERFORMED A HUGE TRACTION WITH CLAMPS WITH THE AIM OF RE-ALIGNING THE ANTERIO-POSTERIOR CURVE, THE TETHERS GOT DAMAGED IN CORRESPONDENCE TO THE TENSIONER. THE DISTAL PART OF THE TETHER WAS CUT AS INDICATED IN THE SURGICAL TECHNIQUE. DEROTATION WAS APPLIED USING GRIPPER AND APPLYING TENSION TO THE CLAMP. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9294284 ↗
• MalfunctionNov 8, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOTIC CURVE CORRECTION AFTER SHE WAS DIAGNOSED WITH SCOLIOSIS. INTRA-OP, WHEN THE SURGEON PERFORMED A HUGE TRACTION WITH CLAMPS WITH THE AIM OF RE-ALIGNING THE ANTERIO-POSTERIOR CURVE, THE TETHERS GOT DAMAGED IN CORRESPONDENCE TO THE TENSIONER. THE DISTAL PART OF THE TETHER WAS CUT AS INDICATED IN THE SURGICAL TECHNIQUE. DEROTATION WAS APPLIED USING GRIPPER AND APPLYING TENSION TO THE CLAMP. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9294256 ↗
• MalfunctionNov 8, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SCOLIOTIC CURVE CORRECTION AFTER SHE WAS DIAGNOSED WITH SCOLIOSIS. INTRA-OP, WHEN THE SURGEON PERFORMED A HUGE TRACTION WITH CLAMPS WITH THE AIM OF RE-ALIGNING THE ANTERIO-POSTERIOR CURVE, THE TETHERS GOT DAMAGED IN CORRESPONDENCE TO THE TENSIONER. THE DISTAL PART OF THE TETHER WAS CUT AS INDICATED IN THE SURGICAL TECHNIQUE. DEROTATION WAS APPLIED USING GRIPPER AND APPLYING TENSION TO THE CLAMP. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9294245 ↗
• InjuryOct 23, 2019Break; Break

  IT WAS REPORTED THAT POST-OP, TRANSLACE BANDS SNAPPED AT SOME POINT. HENCE, ON (B)(6) 2019 A REVISION SURGERY WAS PREFORMED DUE TO TRANSLACE BREAKAGE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9225060 ↗
• InjuryOct 23, 2019Break; Break

  IT WAS REPORTED THAT POST-OP, TRANSLACE BANDS SNAPPED AT SOME POINT. HENCE, ON (B)(6) 2019 A REVISION SURGERY WAS PREFORMED DUE TO TRANSLACE BREAKAGE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9225048 ↗