TSI AL-0103Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843059100945), received between Apr 12, 2024 and May 15, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON 18 MARCH 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON 17 APRIL 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423). THIS REPORT IS 1 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326157 ↗
• MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON 17 APRIL 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:(B)(4), P/N: (B)(6), LOT:1222) & (QTY:(B)(4), P/N: (B)(6), LOT:0423). THIS REPORT IS 5 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED. ON 30 MAY 2024 THE EVALUATION WAS COMPLETED AND AS A RESULT THIS SUPPLEMENTAL REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326064 ↗
• MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON 17 APRIL 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423). THIS REPORT IS 4 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326061 ↗
• MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL (B)(6) RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON (B)(6) 2024 THE (B)(6) RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:(B)(4), P/N: (B)(6), LOT:1222) & (QTY:(B)(4), P/N: (B)(6), LOT:0423). THIS REPORT IS 3 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED. ON 30 MAY 2024 THE EVALUATION WAS COMPLETED AND AS A RESULT THIS SUPPLEMENTAL REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326054 ↗
• MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON 17 APRIL 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423). THIS REPORT IS 2 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326046 ↗
• MalfunctionApr 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON (B)(6) 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423). THIS REPORT IS FOR LOT 1222.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102136 ↗