BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 4770933 · Received May 14, 2015

    Report

    Report Number
    2520274-2015-13822
    Event Type
    Injury
    Date Received
    May 14, 2015
    Report Date
    April 21, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: SIX MONTHS AFTER A T11 TO S1 CONSTRUCT (IMPLANTED (B)(6) 2012) A PATIENT PRESENTED WITH PAIN AFTER FEELING A ¿POP¿ THREE DAYS PRIOR ((B)(6) 2012). X-RAYS SHOWED THAT ONE OF THE TITANIUM RODS HAD BROKEN, NO FURTHER INTERVENTION WAS PLANNED. ON (B)(6) 2012 THE PATIENT EXPERIENCED ANOTHER ¿POP¿; ADDITIONAL X-RAYS SHOWED THAT THE SECOND ROD HAD BROKEN. REVISION SURGERY WAS COMPLETED ON (B)(6) 2013, TWO SUPPORTING RODS WERE ADDED TO THE CONSTRUCT; THE BROKEN RODS WERE NOT EXPLANTED. A FEW WEEKS FOLLOWING THE REVISION, THE PATIENT HEARD ANOTHER ¿POP¿. ON (B)(6) 2014 ALL OF THE HARDWARE WAS EXPLANTED AND A NEW ROD CONSTRUCT WAS IMPLANTED. THE TWO INITIAL RODS WERE REMOVED AND FOUND TO BE BROKEN IN TWO PLACES; THE SUPPORT RODS REMAINED INTACT. THE RETURNED RODS WERE EXAMINED WHERE THE COMPLAINT CONDITION OF ¿BROKEN: POST-OPERATIVELY¿ WAS ABLE TO BE CONFIRMED. BOTH INITIAL RODS WERE FOUND TO BE FRACTURED IN MULTIPLE SECTIONS, A TOTAL OF SEVEN SEGMENTS WERE RETURNED. THE RETURNED RODS SHOWED SIGNIFICANT WEAR/WITNESS MARKS CONSISTENT WITH EXPLANATION. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AGE NOT DETERMINED. EVENT DATE: UNKNOWN. THIS REPORT IS FOR ONE UNKNOWN ROD/UNKNOWN LOT NUMBER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT IS REPORTED PATIENT WAS IMPLANTED WITH UNKNOWN TITANIUM RODS ON (B)(6) 2012 FROM T11 TO S1. PATIENT REPORTED FEELING A "POP" IN (B)(6) 2012 WITH SUBSEQUENT PAIN THREE (3) DAYS LATER. X-RAYS TAKEN AT THAT TIME REVEALED ONE OF THE RODS HAD BROKEN. NO MEDICAL INTERVENTION WAS PLANNED AT THAT TIME. IT IS REPORTED PATIENT HEARD ANOTHER LOUD POP ON (B)(6) 2012. ADDITIONAL X-RAYS REVEALED THE OTHER ROD HAD BROKEN. PATIENT WAS RETURNED TO O.R. ON (B)(6) 2013 WHERE SURGEON ADDED TWO SUPPORT RODS. IT IS REPORTED THE BROKEN RODS WERE NOT EXPLANTED AT THAT TIME. A FEW WEEKS LATER PATIENT REPORTS SQUATTING DOWN AND HEARING ANOTHER POP. PATIENT WAS RETURNED TO O.R. ON (B)(6) 2014 WHERE ALL HARDWARE WAS REMOVED AND PATIENT WAS REVISED TO A NEW ROD CONSTRUCT. IT IS REPORTED THE TWO INITIAL RODS WERE BROKEN IN TWO PLACES, THE SUPPORT RODS ARE INTACT. THIS COMPLAINT IS TO ADDRESS THE SECOND REVISION WHERE ALL HARDWARE WAS EXPLANTED. FIRST REVISION IS ADDRESSED IN (B)(4). THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317376 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention