BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URS Ø4 L25

    MDR report key: 7335243 · Received March 13, 2018

    Report

    Report Number
    8030965-2018-52007
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    February 13, 2018
    Report Date
    February 13, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNI
    UDI-DI
    07611819994836
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW WAS COMPLETED. PART NUMBER: 04.636.425. LOT NUMBER: 9694842 . MANUFACTURING LOCATION: (B)(4). RELEASE TO WAREHOUSE DATE: 21 OCTOBER 2015. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. BECAUSE OF THE EXISTING WEAR OF USE AND DAMAGE ON ALL RECEIVED PARTS AS WELL AS THE REMOVED OR BROKEN OF TABS ON THE URS SCREWS, THE DIMENSIONS CANNOT BE CHECKED TO POST-MANUFACTURING TOLERANCES ANYMORE. ALL PARTS WERE SENT TO THE RESPONSIBLE DEPARTMENT SPINE SUSTAINING ENGINEERING OBERDORF FOR A PRODUCT DEVELOPMENT EVENT INVESTIGATION. SEE ORIGINAL DOCUMENT UNDER NOTES & ATTACHMENTS. THIS COMPLAINT INVOLVES 18 PARTS. DUE TO UNITY CAPACITY INPUT REQUIREMENT TWO COMPLAINTS WERE OPENED: (B)(4). THE 8 LOCKING CAPS (PART: 04. 636.001); 1 URS (PART: 04.636.530); 1 TORQUE LIMITING HANDLE (PART: 03 .620.061). (B)(4): THE 3 LOCKING CAPS (PART: 04.636.001); 3 URS (PART: 04.636.530); 2 URS (PART: 04.636.425). RETURNED FROM CUSTOMER: THE 1* TORQUE LIMITING HANDLE 10NM; ART. NO. 03.636.061; 1 *LOT I UDI NO. (B)(4); 11 *LOCKING CAPS F/URS; ART. NO. 04.636.001; 1* LOT/ UDI NO. L093862; 1 * LOT/ UDI NO. L 103241; 5* LOT/ UDI NO. L 172145; 1* LOT/ UDI NO. 9674735; 2* LOT/ UDI NO. 9913518; 1* LOT/ UDI NO. 9960874; 2* URS 04 L25; ART. NO. 04.636.425; 1* LOT/ UDI NO. 9694842; 1* LOT/ UDI NO. 9828302; 4* URS 05 L30; ART. NO. 04.636.530; 3* LOT/ UDI NO. 3610272; 1* LOT/ UDI NO. 9720753. THE TORQUE LIMITING HANDLE 10NM IS IN A SOUND CONDITION AND SHOWS NO SIGNS OF WEAR AND TEAR. THE COUPLING MECHANISM TO THE SCREWDRIVER WORKS AS INTENDED. A NON-DESTRUCTIVE TEST WAS DONE BY THE POWER TOOLS OUTSIDE US COMPLAINT HANDLING UNIT. RESULTS CAN BE FOUND IN UNITY. THE URS SCREWS WERE RETURNED WITH REMOVED/BROKEN TABS. THE THREADS AND HEADS OF THE SCREWS ARE IN A SOUND CONDITION AND SHOW NORMAL SIGNS OF USE. AS SHOWED IN IMAGE 1 AND 3 (SEE RED CIRCLE AND ARROW) THE LOCKING CAPS WERE SCREWED IN BELOW THE PREDETERMINED BREAKING POINT. THE SCRATCHES, INNER THREADS AND THE SPHERICAL PART OF THE SCREW INDICATE TO THIS. IN TOTAL ELEVEN TWO STEP LOCKING CAPS WERE RETURNED. ALL OUTER THREADS SHOW STRONG SIGNS OF WEAR AND TEAR. WITH THE INFORMATION PROVIDED IN THE COMPLAINT DESCRIPTION A CLEAR STATEMENT CANNOT BE MADE. USUALLY THE TABS SHOULD NOT BREAK IF ALL STEPS ARE FOLLOWED ACCORDING TO THE SURGICAL TECHNIQUE GUIDE. THEREFORE, ONLY ASSUMPTIONS CAN BE MADE. E.G. IF THE COUNTER TORQUE INSTRUMENT (ART. NO. (B)(4)) WAS NOT USED, WITH INCREASING FORCE THE TABS WILL SPREAD OUTWARDS AND FINALLY BREAK. ANOTHER REASON FOR THIS COMPLAINT COULD BE, THAT THE LOCKING CAPS WERE NOT SCREWED IN CORRECTLY. AS MENTIONED IN THE COMPLAINT DESCRIPTION THE FINE METAL WIRES WHEN TURNING THEM OUT WOULD INDICATE TO THIS. CONCLUSION: AS MENTIONED ABOVE, A CLEAR STATEMENT CANNOT BE MADE. IT CAN BE ASSUMED THAT NOT ALL STEPS WERE PERFORMED ACCORDING THE SURGICAL TECHNIQUE GUIDE. THEREFORE, A DESIGN ISSUE CAN BE EXCLUDED FOR THE COMPLAINT EVENTS (B)(4). THE RISK ASSESSMENT FOR URS WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE HARM OF THIS COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS APPROPRIATE. 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 NARRATIVE: NO PATIENT INFORMATION AVAILABLE FOR REPORTING. DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. (B)(6) DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). PROLONGED SEDATION, CHANGE OF MEDICAL PLAN/ADDITIONAL SURGICAL INTERVENTION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SPINE FUSION REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2018 AS UNIVERSAL SPINE SYSTEM (USSII) SCREWS BACKED OUT ACCIDENTALLY AND CAUSED PSEUDOKYPHOSIS FROM C7 TO T2. THE SURGEON PLANNED TO USE REDUCTION SCREWS AND RECONNECTING WITH USSII FOR THE REVISION; HOWEVER, THE SURGICAL PLAN WAS CHANGED TO USING THE UNIVERSAL REDUCTION SCREW (URS) SYSTEM FOR THIS SURGERY. INTRAOPERATIVE EVENT OCCURRED WHEN SURGEON WAS TIGHTENING THE URS LOCKING SCREW (LOCKING CAPS) TO THE URS SCREWS. THE SURGEON FOUND WHEN THEY USED THE TORQUE SCREWDRIVER INTRAOPERATIVELY TO TIGHTEN THE SET SCREWS (LOCKING CAPS) EVEN USING THE COUNTER TORQUE, THE SET SCREWS (LOCKING CAPS) WOULDN¿T SIT SECURELY ON THE SCREW HEAD AND ALSO EXPANDED THE SCREW HEAD AND BROKE THE SETS SCREWS (LOCKING SCREWS) BY TURNING OUT WITH SOME FINE METAL FRAGMENTS. SURGEONS HAD CHANGED THE URS SET SCREWS (LOCKINGS SCREWS) WITH THE NEW ONE BUT THE RESULTS WERE THE SAME UNLESS HE TRIED NOT TO TIGHTEN TILL THE TORQUE LIMIT. THE SURGEON HAD DIFFICULTY ASSEMBLING SCREWS WITH PLATE (ROD). FINALLY, SURGEON USED ELEVEN (11) URS SET SCREWS (LOCKING CAPS) FOR SIX (6) URS SCREWS, BUT WAS WORRIED ABOUT THE LOCKING NOT SECURE, SO DECIDED TO REMOVE ALL URS SCREWS AND URS LOCKING CAPS. THE SURGEON THEN USED THE CURRENT USSII SYSTEM TO COMPLETE THE REVISION SURGERY. SURGERY WAS DELAYED FOR ONE (1) HOUR DUE TO REPORTED INTRAOPERATIVE ISSUE. PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES TOTAL 18 PARTS. THIS COMPLAINT IS SPLIT INTO TWO COMPLAINTS: (B)(4) CAPTURES: 8 LOCKING CAPS (PART: 04.636.001), 1 URS (PART: 04.636.530), 1 TORQUE LIMITING HANDLE (PART: 03.620.061). (B)(4) CAPTURES: 3 LOCKING CAPS (PART: 04.636.001), 3 URS (PART: 04.636.530), 2 URS (PART: 04.636.425). CONCOMITANT DEVICE REPORTED: ROD (PART UNKNOWN, LOT UNKNOWN, QTY UNKNOWN). THIS REPORT IS FOR ONE (1) URS Ø4 L25. (B)(4).

    Description of Event or Problem · 1

    PATIENT OUTCOME WAS REPORTED AS STABLE. (B)(4) CAPTURES ISSUES OCCURRED DURING THE REVISION SURGERY. (B)(4) ADDRESSES THE REVISION SURGERY DUE TO BACKED OUT SCREWS CAUSING PSEUDOKYPHOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178018 URS Ø4 L25 ORTHOSIS,PEDICLE SPINAL FIXATION MNI OBERDORF SYNTHES PRODUKTIONS GMBH 9694842 07611819994836

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention