Matrix 09.632.099Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034763194), received between Apr 2, 2018 and Dec 11, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2024. THE FINAL TIGHTENING OF THE LOCK-CAP IN QUESTION COULD NOT BE PERFORMED PROPERLY BECAUSE IT WAS CROSS-THREADED. ANOTHER NEW ONE WAS OPENED ADDITIONALLY. THIS HOSPITAL ADMINISTRATIVELY RECORDS PRODUCTS THAT HAVE NOT ULTIMATELY IMPLANTED IN THE BODY BY CHECKING THE LOT NUMBER AS ¿ONCE IMPLANTED IN THE BODY, BUT NOT ULTIMATELY REMAINING IN THE BODY.¿ AS A COMPLAINT ABOUT THE PRODUCT'S SPECIFICATIONS OR DESIGN, THE HOSPITAL COMPLAINED AS FOLLOWS: THE LOT NUMBER ON THE OUTER PACKAGE AND STICKER DOES NOT MATCH THE LOT NUMBER ENGRAVED ON THE MATRIX PRODUCT, MAKING IT DIFFICULT TO IDENTIFY AND MANAGE THE PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE LOT NUMBER ENGRAVED ON THE PRODUCT IN QUESTION WAS "3811P03".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905897 ↗
• InjuryApr 2, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION ON (B)(6) 2018 DUE A MATRIX LOCKING CAP THAT HAD COME OFF AND A NON-SYNTHES GRAFT HAD MIGRATED POST-OPERATIVELY. THE PATIENT HAD BEEN AWAKENED BY A FAMILY MEMBER THE DAY AFTER SURGERY AND WAS STARTLED, CAUSING HER TO LEAP FROM THE BED. SHE BEGAN TO PRESENT WITH PAIN AND RADICULOPATHY, SO A NEW MAGNETIC RESONANCE IMAGING (MRI) WAS ORDERED. THE MRI APPEARED TO SHOW THE PATIENT¿S HARDWARE IN GOOD POSITION WITH NO INTERBODY MIGRATION AND THE SCREWS APPEARED TO BE IN A GOOD POSITION. AFTER REVIEWING THE MRI, X-RAYS WERE REVIEWED, WHICH HAD BEEN TAKEN SEVERAL DAYS AFTER THE POST-OPERATIVE MRI BECAUSE THE PATIENT¿S PAIN HAD BEEN INTENSIFYING. THE X-RAYS REVEALED THAT A MATRIX LOCKING CAP HAD COME OFF AND THE NON-SYNTHES CONCORDE BULLET TI GRAFT WHICH HAD BEEN IN A GOOD POSITION, HAD PARTIALLY EXTRUDED, AND HAD SETTLED WITH A PORTION OF THE GRAFT IN THE FORAMEN. THE SURGEON DETERMINED THAT A REVISION SURGERY NEEDED TO BE DONE. HE INSTRUCTED THE PATIENT TO COME TO THE EMERGENCY ROOM AND THAT A REVISION PROCEDURE WOULD BE PERFORMED. THE DOCTOR OPENED THE EXISTING INCISION AND LOCATED THE AFFECTED HARDWARE. THE CAP WAS REMOVED FROM THE WOU

  Patient problems: Not Applicable

  MAUDE report 7388242 ↗