Reform HA Coated Pedicle Screw System 39-PH-7540Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815362020234), received between Sep 10, 2019 and Sep 10, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2019Loose or Intermittent Connection

  INFORMATION PROVIDED, ALONG WITH SALES HISTORY, INDICATES THAT THE PATIENT UNDERWENT A SINGLE LEVEL FUSION PROCEDURE ON (B)(6) 2019, UTILIZING THE REFORM HA COATED STERILE PEDICLE SCREWS. SUBSEQUENTLY, THE PATIENT PRESENTED WITH INFECTION AND PROCEDURES WERE PERFORMED (B)(6) 2019, (B)(6) 2019 & (B)(6) 2019. NO DETAILS REGARDING THESE PROCEDURES WERE AVAILABLE, BUT BASED ON SALES HISTORY INFORMATION, IT APPEARS THAT DURING THE PROCEDURE PERFORMED ON (B)(6) 2019 TO ADDRESS INFECTION, FOUR (4) REFORM HA COATED PEDICLE SCREWS 7.5MM X 40MM (LOT 15351PS) THAT WERE IMPLANTED DURING THE INITIAL PROCEDURE WERE REMOVED AND REPLACED DUE TO LOOSENING CAUSED BY INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8980998 ↗
• InjurySep 10, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  INFORMATION PROVIDED, ALONG WITH SALES HISTORY, INDICATES THAT THE PATIENT UNDERWENT A SINGLE LEVEL FUSION PROCEDURE ON (B)(6) 2019, UTILIZING THE REFORM HA COATED STERILE PEDICLE SCREWS. SUBSEQUENTLY, THE PATIENT PRESENTED WITH INFECTION AND PROCEDURES WERE PERFORMED (B)(6) 2019, (B)(6) 2019 & (B)(6) 2019. NO DETAILS REGARDING THESE PROCEDURES WERE AVAILABLE, BUT BASED ON SALES HISTORY INFORMATION, IT APPEARS THAT DURING THE PROCEDURE PERFORMED ON (B)(6) 2019 TO ADDRESS INFECTION, FOUR (4) REFORM HA COATED PEDICLE SCREWS 7.5MM X 40MM (LOT 15351PS) THAT WERE IMPLANTED DURING THE INITIAL PROCEDURE WERE REMOVED AND REPLACED DUE TO LOOSENING CAUSED BY INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8980996 ↗
• InjurySep 10, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  INFORMATION PROVIDED, ALONG WITH SALES HISTORY, INDICATES THAT THE PATIENT UNDERWENT A SINGLE LEVEL FUSION PROCEDURE ON (B)(6) 2019, UTILIZING THE REFORM HA COATED STERILE PEDICLE SCREWS. SUBSEQUENTLY, THE PATIENT PRESENTED WITH INFECTION AND PROCEDURES WERE PERFORMED (B)(6) 2019, (B)(6) 2019 & (B)(6) 2019. NO DETAILS REGARDING THESE PROCEDURES WERE AVAILABLE, BUT BASED ON SALES HISTORY INFORMATION, IT APPEARS THAT DURING THE PROCEDURE PERFORMED ON (B)(6), 2019 TO ADDRESS INFECTION, FOUR (4) REFORM HA COATED PEDICLE SCREWS 7.5MM X 40MM (LOT 15351PS) THAT WERE IMPLANTED DURING THE INITIAL PROCEDURE WERE REMOVED AND REPLACED DUE TO LOOSENING CAUSED BY INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8980995 ↗
• InjurySep 10, 2019Loose or Intermittent Connection

  INFORMATION PROVIDED, ALONG WITH SALES HISTORY, INDICATES THAT THE PATIENT UNDERWENT A SINGLE LEVEL FUSION PROCEDURE ON (B)(6) 2019, UTILIZING THE REFORM HA COATED STERILE PEDICLE SCREWS. SUBSEQUENTLY, THE PATIENT PRESENTED WITH INFECTION AND PROCEDURES WERE PERFORMED (B)(6) 2019. NO DETAILS REGARDING THESE PROCEDURES WERE AVAILABLE, BUT BASED ON SALES HISTORY INFORMATION, IT APPEARS THAT DURING THE PROCEDURE PERFORMED ON (B)(6) 2019 TO ADDRESS INFECTION, FOUR (4) REFORM HA COATED PEDICLE SCREWS 7.5MM X 40MM (LOT 15351PS) THAT WERE IMPLANTED DURING THE INITIAL PROCEDURE WERE REMOVED AND REPLACED DUE TO LOOSENING CAUSED BY INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8980994 ↗