BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI POLYAXIAL HEAD FOR USS POLYAXIAL

    MDR report key: 8607707 · Received May 14, 2019

    Report

    Report Number
    8030965-2019-63901
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 15, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKB
    UDI-DI
    07611819186361
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DATE OF EVENT: UNKNOWN DATE IN (B)(6) 2019. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6: PICTURE REVIEW: NARRATIVE (DISENGAGEMENT OF SCREW HEADS AND CRACKED USS-II POLYAXIAL 3D-HEAD) COULD BE VERIFIED FROM PROVIDED X-RAYS AND VIDEO. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. SEVERAL PARTS OF THE USS-II POLYAXIAL SYSTEM WERE RETURNED FOR INVESTIGATION DUE TO CLICKING SOUND DURING USE OR EVEN DUE TO THE CRACKING OF SOME CLAMPING RINGS OF THE USS-II POLYAXIAL 3D-HEADS. THE FINAL PRODUCT ART. 04.607.402 IS THE ASSEMBLY OF TWO COMPONENT PARTS (PART# 50161103 CLAMPING RING AND PART# 50161100 BODY). THE RETURNED USS-II POLYAXIAL 3D-HEAD THAT WERE ALLOCATED TO (B)(4) ARE INTACT, THE CLAMPING RINGS ARE NOT CRACKED. HOWEVER, THE PARTS WERE FORWARDED TO THE MANUFACTURING SITE AS WELL AS TO THE RESPONSIBLE PRODUCT DEVELOPMENT CENTER (PDC) FOR EVALUATION. SUMMARY MANUF EVAL: THE RETURNED CLAMPING RING COMPONENTS (PART# 50161103) HAVE BEEN FOUND INTERNALLY DAMAGED DUE TO THE USE BUT NOT CRACKED AS REPORTED ON THE COMPLAINT DESCRIPTION. THE RETURNED ITEMS HAVE BEEN DIMENSIONALLY REINSPECTED AND ALL THE MEASURABLE FEATURES RELEVANT TO THE COMPLAINT DESCRIPTION HAVE BEEN FOUND CONFORMING TO SPECIFICATION. THE INVESTIGATIONS PERFORMED DIDN¿T IDENTIFY ANY MANUFACTURING DEFECT OR DEFICIENCY, THUS THE COMPLAINT INVESTIGATION IS CONSIDERED AS NOT MANUFACTURING RELATED. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT ALL INVOLVED PARTS WERE MANUFACTURED IN ACCORDANCE TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. PARTS WERE FORWARDED TO THE MANUFACTURING SITE FOR EVALUATION, IN ADDITION SOME CLAMPING RINGS WERE FORWARDED TO AN EXTERNAL LABORATORY FOR MATERIAL ANALYSIS AS WELL AS ONE CLAMPING RING WAS INVESTIGATED BY OUR INTERNAL LABORATORY (MATERIAL&TESTING). THE DIMENSIONAL RE-INSPECTION, THE RAW MATERIAL CERTIFICATE REVIEW AND THE DOCUMENT/SPECIFICATION REVIEW DIDN¿T IDENTIFY ANY MANUFACTURING DEFECT OR DEFICIENCY, THUS THE COMPLAINT INVESTIGATION IS CONSIDERED AS NOT MANUFACTURING RELATED. BASED ON THE EXAMINATION OF THE FRACTURE SURFACES IT CAN BE CONCLUDED THAT THE CLAMPING RINGS WERE SUBJECTED TO MULTIAXIAL FORCES, PROBABLY CAUSED BY A COMBINATION OF THE ROD, SLEEVE AND 3D-HEAD PRESSING ON THE CLAMPING RINGS, WHICH LED TO A MATERIAL OVERLOAD AND FRACTURE. THE WEAR MARKS ON THE RINGS SUGGEST, THAT SOME MOVEMENT WAS INVOLVED AFTER THE CLAMPING RINGS WERE PUT IN PLACE. THE MATERIAL PROPERTIES WERE CHECKED AND FOUND TO BE IN ACCORDANCE WITH THE INTERNATIONAL STANDARDS ISO 5832-11:2014 AND ASTM F1295 - 16 FOR IMPLANTS MADE OF TITANIUM ALLOY (TI6AL7NB) AS WELL AS WITH THE INTERNAL RAW MATERIAL SPECIFICATIONS ES0396 ¿IMPLANT QUALITY TI-6AL-7NB TITANIUM ALLOY ANNEALED ROUND BAR (INTERNAL REQUIREMENTS MEET OR EXCEED THOSE ESTABLISHED IN ASTM F1295 AND ISO 5832 -11). THE INVESTIGATION FOUND NO MATERIAL OR MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE COMPLAINTS (B)(4) ARE CONFIRMED SINCE SOME OF THE CLAMPING RINGS OF THE USS II POLY 3-D HEADS ARE CRACKED. THE INVESTIGATION REGARDING DIMENSIONS AND RAW MATERIAL COULD NOT DETECT ANY NON-CONFORMITIES OR OTHER IRREGULARITIES THAT COULD POTENTIALLY HAVE AN INFLUENCE ON THE FUNCTION OR MECHANICAL STRENGTH OF THE DEVICE. THE EXACT CAUSE OF FAILURE COULD NOT BE IDENTIFIED. FURTHER ROOT CAUSE ANALYSIS IS STILL ONGOING, IN THIS REGARD A PRODUCT ISSUE ESCALATION HAS BEEN INITIATED AND AS A PREVENTIVE ACTION A STOP SHIPMENT FOR ALL USS-II POLYAXIAL 3D-HEAD MANUFACTURED FROM RAW MATERIAL L858041) WAS STARTED. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 04.607.402 , LOT: 3L08448 , MANUFACTURING SITE: MEZZOVICO , RELEASE TO WAREHOUSE DATE: 10 JAN 2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6: PATIENT CODE 3191 USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. 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 · 0

    CONCOMITANT DEVICES REPORTED: UNKNOWN ROD (PART# UNKNOWN. LOT# UNKNOWN, QUANTITY 1), USS-II POLYAXIAL 3D-HEAD (PART#04.607.402, LOT#2L40723, QUANTITY#1), USS-II POLYAXIAL 3D-HEAD (PART#04.607.402, LOT#UNKNOWN, QUANTITY#1), TI USS POLYAXIAL SCREW (PART#04.607.056, LOT#UNKNOWN, QUANTITY#1), USS POLYAXIAL TI COLLAR (PART#04.607.412, LOT#2L00359, QUANTITY#5), USS POLYAXIAL TI COLLAR (PART#04.607.412, LOT#1L93021, QUANTITY#1), TI 12 POINT NUT (PART#499.294, LOT#2L21501, QUANTITY#2), TI 12 POINT NUT (PART#499.294, LOT#2L89034, QUANTITY#1), TI 12 POINT NUT (PART#499.294, LOT#1L70497, QUANTITY#2), TI 12 POINT NUT (PART#499.294, LOT#1L62386 QUANTITY#1),

    Description of Event or Problem · 0

    CONCOMITANT DEVICES REPORTED: SOCKET WRENCH (PART#388.584, LOT#1485395, QUANTITY#1); REMOBILIZATION TOOL FOR USS POLYAXIAL (PART#03.603.108, LOT#8830014, QUANTITY#1); REMOBILIZATION TOOL FOR USS POLYAXIAL (PART#03.603.108, LOT#3179617, QUANTITY#1); INTERNAL COUNTER TORQUE WITH T-HANDLE (PART#388.143, LOT#3419211, QUANTITY#1) ; USS-II POLYAX POSITION PLIERS (PART#03.607.004, LOT#1694845, QUANTITY#1); USS-II POLYAX POSITION PLIERS (PART#03.607.004, LOT#1474662, QUANTITY#1); TORQUE LIMITING HANDLE (PART#03.602.042, LOT# 7296830-02, QUANTITY#1) ; USS-II POLYAXIAL 3D-HEAD (PART#04.607.402, LOT#2L40723, QUANTITY#1) ; USS-II POLYAXIAL 3D-HEAD (PART#04.607.402, LOT#UNKNOWN, QUANTITY#1); TI USS POLYAXIAL SCREW (PART#04.607.056, LOT#UNKNOWN, QUANTITY#1) ; USS POLYAXIAL TI COLLAR (PART#04.607.412, LOT#2L00359, QUANTITY#5); USS POLYAXIAL TI COLLAR (PART#04.607.412, LOT#1L93021, QUANTITY#1) ; TI 12 POINT NUT (PART#499.294, LOT#2L21501, QUANTITY#2); TI 12 POINT NUT (PART#499.294, LOT#2L89034, QUANTITY#1) ; TI 12 POINT NUT (PART#499.294, LOT#1L70497, QUANTITY#2); TI 12 POINT NUT (PART#499.294, LOT#1L62386 QUANTITY#1).

    Description of Event or Problem · 0

    UPON REVIEW OF THE RECEIVED X-RAYS IT WAS IDENTIFIED THAT SCREWS ARE BROKEN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES MNI, MNH, KWP, KWQ. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISENGAGEMENT OF THE SCREW HEADS ON THE TOP RIGHT AND ON THE TOP LEFT OF THE CONSTRUCT FROM THE SCREW SHAFTS POST-OPERATIVELY. THE PATIENT COMPLAINED OF BACK PAIN AND AN X-RAY TAKEN (B)(6) 2019, REVEALED THE DISENGAGEMENT OF THE SCREWS. INITIALLY, THE PATIENT HAD IMPLANTATION ON AN UNKNOWN DATE. IN THE REVISION SURGERY, ALL SCREW HEADS WERE REPLACED WITH SOME OF THE REMOVED SCREW HEADS VISIBLY CRACKED. AFTER TIGHTENING THE NEW SCREW HEADS USING A SOCKET WRENCH 5.0 MM WITH T-HANDLE, A SOCKET WRENCH FOR 12-POINT NUT L-HANDLE, AND A TORQUE LIMITING HANDLE, A METALLIC SOUND WAS AUDIBLE. DUE TO THIS SOUND, ALL SCREW HEADS WERE REMOVED AGAIN. TO REPLACE THE SCREW HEADS AND APPROXIMATE THE ROD, A ROD CRIMPING PLIERS FOR USS IMPLANTS AND USS II POLYAXIAL ROD INTRODUCTION PLIERS FOR RODS WERE USED. TO TIGHTEN THE SCREW HEADS, A TORQUE LIMITING HANDLE FROM THE NEW SET WAS USED AND NO METALLIC SOUND WAS AUDIBLE. DURING SURGERY, THREE (3) USS STICKS II POLYAXIAL SCREW HOLDER WERE BROKEN. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWO (2) HOUR SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: SOCKET WRENCH (PART#388.584, LOT#1485395, QUANTITY#1). REMOBILIZATION TOOL FOR USS POLYAXIAL (PART#03.603.108, LOT#8830014, QUANTITY#1). REMOBILIZATION TOOL FOR USS POLYAXIAL (PART#03.603.108, LOT#3179617, QUANTITY#1). INTERNAL COUNTER TORQUE WITH T-HANDLE (PART#388.143, LOT#3419211, QUANTITY#1). USS-II POLYAX POSITION PLIERS (PART#03.607.004, LOT#1694845, QUANTITY#1). USS-II POLYAX POSITION PLIERS (PART#03.607.004, LOT#1474662, QUANTITY#1). TORQUE LIMITING HANDLE (PART#03.602.042, LOT# 7296830-02, QUANTITY#1). THIS REPORT IS FOR ONE (1) TI POLYAXIAL HEAD FOR USS POLYAXIAL. THIS IS REPORT 5 OF 5 FOR (B)(4). THIS COMPLAINT CAPTURES THE POST-OPERATIVE EVENT, WHILE (B)(4) CAPTURES THE INTRA-OPERATIVE EVENTS DURING REVISION SURGERY ON (B)(6) 2019, THEN (B)(4) CAPTURES THE INTRAOPERATIVE EVENT DURING REVISION ON (B)(6) 2019, AND (B)(4) ALSO CAPTURES POSTOPERATIVE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403328 TI POLYAXIAL HEAD FOR USS POLYAXIAL ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB OBERDORF SYNTHES PRODUKTIONS GMBH 3L08448 07611819186361

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA| REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA| REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA| REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA| SOCKET-WRENCH F/12POINT NUT W/L-HANDLE| SOCKET-WRENCH F/12POINT NUT W/L-HANDLE| SOCKET-WRENCH Ø5 W/T-HANDLE| SOCKET-WRENCH Ø5 W/T-HANDLE| TORQUE-LIMITING HANDLE 12NM F/USS-II| TORQUE-LIMITING HANDLE 12NM F/USS-II| UNK - RODS| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II NUT TAN GREEN| USS-II POLYAX PEDICSCR Ø7 L50 TAN GREEN| USS-II POLYAX PEDICSCR Ø7 L50 TAN GREEN| USS-II POLYAX POSITIONPLIERS F/3D-HEADS| USS-II POLYAX POSITIONPLIERS F/3D-HEADS| USS-II POLYAX POSITIONPLIERS F/3D-HEADS| USS-II POLYAX POSITIONPLIERS F/3D-HEADS| USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE| USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE| USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE| USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| REMOBILIZATION TOOL F/LOTUS+USS-II-POLYA.| SOCKET-WRENCH F/12POINT NUT W/L-HANDLE.| SOCKET-WRENCH Ø5 W/T-HANDLE.| TORQUE-LIMITING HANDLE 12NM F/USS-II.| USS-II POLYAX POSITIONPLIERS F/3D-HEADS.