BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI HARD ROD 125MM

    MDR report key: 5014009 · Received August 19, 2015

    Report

    Report Number
    2520274-2015-15303
    Event Type
    Injury
    Date Received
    August 19, 2015
    Report Date
    August 3, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK090605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED ¿ FIVE 6.0MM PANGEA POLYAXIAL SCREWS (PART# 04.620.645, LOT# 7059241, 7177835, 5883928, 7182324, 7177838), FIVE LOCKING CAPS (PART# 04.620.000, LOT# 7212831 QTY (B)(4), 7183995 QTY (B)(4)), ONE TRANSCONNECTOR (PART# 04.620.204, LOT# 6690662), TWO PARALLEL CONNECTORS (PART# 498.160, LOT# 6835464, QTY (B)(4)) ONE EXTENSION CONNECTOR (PART# 498.165, LOT# 7695223) AND TWO TITANIUM RODS (PART# 498.106 LOT #: 6430550, PART# 498.105 LOT #: 0784868) WERE RETURNED FOR THE SCREWS NOT BEING WELL IMPLANTED AND THE PATIENT'S BONE NOT GROWING AROUND THEM. THIS COULD BE A RESULT OF POOR BONE QUALITY, THE LOCKING CAPS NOT BEING TIGHTENED TO THE APPROPRIATE TORQUE, OR A REACTION TO THE TAN ALLOY OF THE SCREWS. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AND THE COMPLAINT IS CONFIRMED. THE RODS WERE RETURNED CHIPPED AND NICKED AND ALSO HAD THE ANODIZATION WORN OFF IN SPOTS. THE TRANSCONNECTOR WAS RETURNED WITH THE SCREW HOLDING THE TWO HOOKS TOGETHER MISSING. NO OTHER DAMAGE VISIBLE ON THE COMPONENTS. THE TWO PARALLEL CONNECTORS WERE RETURNED WITH ALL OF THE SET SCREWS AND MINIMAL DAMAGE. THE LOCKING CAPS CONTAINED MINIMAL DAMAGE BUT SHOWED WEAR ON THE RIDGED SURFACE THAT INTERFACES WITH THE RODS. THE STRAIGHT CONNECTOR HAD MINIMAL DAMAGE AND ALL SET SCREWS. IT IS UNLIKELY THE RETURNED LOCKING CAPS, RODS, AND CONNECTORS CONTRIBUTED TO THIS COMPLAINT AS THEY DO NOT DIRECTLY AFFECT THE SCREW PURCHASE. THE DETAILS REGARDING THE TECHNIQUE USED AND THE BONE QUALITY OF THE PATIENT ARE UNKNOWN AND SO THE ROOT CAUSE CANNOT BE DETERMINED. DHR REVIEW ¿ MANUFACTURE DATE: 12-02-11. AFTER REVIEWING THE PICTURES, IT CANNOT BE DEFINITIVELY ESTABLISHED THAT THE LOT NUMBER IS CORRECT, BUT IT IS A SAFE ASSUMPTION THAT THE LOT NUMBER IS 6784868. THERE ARE THREE RAW MATERIAL LOT NUMBER ASSOCIATED WITH THIS ROD: ONE LOT CHANGED (RAW MATERIAL ASSOCIATED WITH ROD) WHEN REWORKED FOR ETCH - RAW MATERIAL IDENTIFICATION AND ONE LOT WAS CHANGED AFTER SORT FOR DIMENSIONAL AND VISUAL NONCONFORMITIES. ONE LOT HAD AN NCR TO BE 100% SORTED TO TIGHTER TOLERANCE AND CHECKED 100% FOR VISUAL NONCONFORMITIES. THE SORTED CONFORMING MATERIAL WAS USED TO MAKE THE ROD. SORTING FOR DIMENSIONAL AND VISUAL NONCONFORMITIES WOULD NOT CAUSE SCREW TO PULL OUT OF POOR QUALITY BONE. NO OTHER DISCREPANCIES WERE NOTED THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT. 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

    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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    ADDITIONAL PRODUCT CODES: MNI, MNH, KWP, KWQ. (B)(6) THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED A REMOVAL SURGERY WAS PERFORMED. THIS WAS THE PATIENT'S THIRD SURGERY; THE FIRST SURGERY WAS ON (B)(6) 2013 AND THE SECOND SURGERY WAS ON (B)(6) 2013. THE FIRST SURGERY ENTAILED AN ILLIAC-L1 FUSION UTILIZING THE PANGEA SYSTEM. THE SECOND SURGERY WAS PERFORMED DUE TO THE FACT THAT TWO OF THE INITIAL SCREWS WERE PULLING OUT OF THE BONE DUE TO THE PATIENT'S POOR BONE QUALITY AND ENTAILED T11-T8 EXTENSION FROM THE FIRST SURGERY ALSO USING THE PANGEA SYSTEM, WITH DOMINOS. THE TWO (2) SCREWS THAT WERE PULLING OUT WERE LEFT IN THE PATIENT. APPROXIMATELY TWO YEARS LATER, THE PATIENT COMPLAINED OF BACK PAIN AND THE SURGEON REALIZED THAT THE SCREWS INSERTED FROM T11-T8 WERE NOT WELL IMPLANTED INTO THE BONE. UPON MRI, THE SURGEON DISCOVERED THAT AROUND THE SCREWS A VOID WAS BEING CREATED AND THE BONE WAS NOT GROWING AROUND THE SCREW, HENCE NO FUSION WAS OCCURRING. CONSEQUENTLY ON (B)(6) 2015, THE SURGEON PERFORMED A REMOVAL SURGERY WHEN SCREWS FROM T11-T8 WERE REMOVED ALONG WITH DOMINOS, CROSSLINKS, SCREWS AND CAPS. ALL ORIGINALLY IMPLANTED SCREWS WERE LEFT IN THE PATIENT AS FUSION HAD OCCURRED AT THE SITE WHERE THE ORIGINAL SCREWS HAD PULLED OUT. THE SURGEON KEPT TWO SCREWS IN ORDER TO PERFORM ALLERGY TESTS. IT WAS ALSO REPORTED THAT THE SCREWS WERE REMOVED VERY EASILY. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 15 OF 16 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548788 6.0MM TI HARD ROD 125MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 6784868

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention