BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LENGTH

    MDR report key: 5013395 · Received August 19, 2015

    Report

    Report Number
    2530088-2015-10546
    Event Type
    Injury
    Date Received
    August 19, 2015
    Report Date
    August 3, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK103287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW ¿ MANUFACTURE DATE: 01-11-13. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    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 3, 7183995 QTY 2), ONE TRANSCONNECTOR (PART# 04.620.204, LOT# 6690662), TWO PARALLEL CONNECTORS (PART# 498.160, LOT# 6835464, QTY 2) 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. ALL FIVE SCREWS WERE RETURNED WITH THE POLYAXIAL HEADS NO LONGER ABLE TO ROTATE ON THE SCREW HEAD. THE ANODIZATION WAS WORN OFF AT SPOTS ON THE THREAD SHAFTS. THE TOPS OF THE POLYAXIAL HEADS WERE DAMAGED AS ONLY SCREW 7182324 WOULD ACCEPT A LOCKING CAP. THE STRAIGHT CONNECTOR HAD MINIMAL DAMAGE AND ALL SET SCREWS. THE PANGEA DEGENERATIVE TECHNIQUE GUIDE WAS REVIEWED DURING THE EVALUATION. THE POLYAXIAL SCREWS ARE DESIGNED WITH A DOUBLE CORE THREAD DESIGN CONTAINING A CORTICAL THREAD TO ENGAGE THE PEDICLE AND A CANCELLOUS THREAD TO ENGAGE THE VERTEBRAL BODY. THE TECHNIQUE GUIDE INCLUDES A WARNING STATING THAT PANGEA SCREW IMPLANTS ACHIEVE PERFORMANCE STANDARD ONLY WHEN TIGHTENED TO THE REQUIRED 10NM TIGHTENING TORQUE. NOT TIGHTENING A LOCKING CAP TO THE REQUIRED 10NM MAY HAVE CAUSED INSTABILITY IN THE CONSTRUCT AND ALLOWED THE SCREWS TO BECOME LOOSE. AS STATED IN THE COMPLAINT DESCRIPTION, THE PATIENT HAS POOR BONE QUALITY. THIS CAN CREATE A ¿WINDSHIELD WIPER EFFECT¿ CREATING A VOID IN THE BONE AND CAUSING THE SCREW TO BECOME LOOSE. ALSO, UNDER THE ¿DEVICE RELATED ISSUES¿ IN THE EVENT FORM IT WAS STATED THAT A POSSIBLE BONE ¿REACTION¿ AROUND THE SCREW CREATED A ZERO BONE PURCHASE IN THE PEDICLE AND THE SURGEON KEPT TWO SCREWS FOR AN ALLERGY TEST. THE SCREWS ARE MADE FROM A TITANIUM, ALUMINUM, NIOBIUM ALLOY AND SO IF THE PATIENT HAD AN ALLERGY TO TITANIUM IT MAY HAVE AFFECTED THE SCREW PURCHASE IN THE BONE. 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. THE SCREW LOOSENING/POOR IMPLANTATION MAY HAVE BEEN 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. GIVEN THE INFORMATION AVAILABLE, AN EXACT ROOT CAUSE COULD NOT 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

    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

    PATIENT ID IS UNKNOWN. PATIENT¿S WEIGHT IS UNKNOWN BUT REPORTED AS NORMAL. 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)(6) 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 4 OF 16 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547678 6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 7182324

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention