OsteoSelect (DBM) Putty 10.0cc in a Syringe 359100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00849777003681), received between Mar 21, 2017 and Nov 19, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K130498); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2020Improper or Incorrect Procedure or Method; Expiration Date Error; Improper or Incorrect Procedure or Method; Expiration Date Error

  THE COMPANY RECEIVED NOTIFICATION ON 10/21/2020 FROM A SALES DISTRIBUTOR THAT A COMBINATION PRODUCT GRAFT HAD BEEN IMPLANTED BEYOND THE EXPIRATION DATE IDENTIFIED ON THE PRODUCT PACKAGE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS REPORT OF AN IMPLANTED EXPIRED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10872245 ↗
• MalfunctionMay 8, 2019Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information

  A COMPLAINT WAS REPORTED ON (B)(6) 2019 INDICATING THAT DEVICES CONTAINING DBM PUTTY WERE LABELED WITH A VOLUME OF 10.0CC, HOWEVER, WHEN THE POUCHES WERE OPENED FOR USE, THE SYRINGES CONTAINED 5.0CC OF DBM PUTTY. THE COMPLAINANT REPORTED THAT THREE DEVICES DISPLAYING THE SAME DEFECT HAD BEEN IMPLANTED. THE FOLLOWING MDR SUBMISSIONS ARE RELATED TO THIS EVENT: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8592175 ↗
• MalfunctionMay 8, 2019Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information

  A COMPLAINT WAS REPORTED ON (B)(6) 2019 INDICATING THAT DEVICES CONTAINING DBM PUTTY WERE LABELED WITH A VOLUME OF 10.0CC, HOWEVER, WHEN THE POUCHES WERE OPENED FOR USE, THE SYRINGES CONTAINED 5.0CC OF DBM PUTTY. THE COMPLAINANT REPORTED THAT THREE DEVICES DISPLAYING THE SAME DEFECT HAD BEEN IMPLANTED. THE FOLLOWING MDR SUBMISSIONS ARE RELATED TO THIS EVENT: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8592174 ↗
• MalfunctionMay 8, 2019Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information

  A COMPLAINT WAS REPORTED ON (B)(6) 2019 INDICATING THAT DEVICES CONTAINING DBM PUTTY WERE LABELED WITH A VOLUME OF 10.0CC, HOWEVER, WHEN THE POUCHES WERE OPENED FOR USE, THE SYRINGES CONTAINED 5.0CC OF DBM PUTTY. THE COMPLAINANT REPORTED THAT THREE DEVICES DISPLAYING THE SAME DEFECT HAD BEEN IMPLANTED. THE FOLLOWING MDR SUBMISSIONS ARE RELATED TO THIS EVENT: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8592169 ↗
• MalfunctionMar 21, 2017Shelf Life Exceeded; Shelf Life Exceeded

  THE COMPANY WAS NOTIFIED ON 02/24/2017 THAT AN EXPIRED PRODUCT WAS IMPLANTED INTO A PATIENT ON (B)(6) 2017. THE PRODUCT'S EXPIRATION DATE WAS 02/08/2017. THE HOSPITAL WAS NOTIFIED BY THE COMPANY ON 02/20/2017 THAT THEY HAD AN EXPIRED GRAFT IN INVENTORY. SUBSEQUENT COMMUNICATION WITH THE HOSPITAL ON 03/10/2017, REVEALED THAT AN EMPLOYEE ABSENCE COULD HAVE CONTRIBUTED TO THE INCIDENT DESPITE THE NOTIFICATION FROM THE COMPANY. PATIENT DISCHARGED ON (B)(6) 2017 WITH NO KNOWN COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6421696 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130498. One submission often covers many models, so check the product and lot details in each record.

• Z-1526-2020 · May 3, 2019 · Terminated
  OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Produc