UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM
Report
- Report Number
- 1526439-2024-01767
- Event Type
- Malfunction
- Date Received
- July 2, 2024
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL CH
- Product Code
- MNI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D1, D2A, D2B, D3, D4, G4 ¿ 510K: THIS REPORT IS FOR AN UNKNOWN MONO/POLYAXIAL SCREWS: EXPEDIUM/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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.
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: CORRECTED DATA: E1: INITIAL REPORTER FACILITY INFORMATION UPDATED. H10: RELATED REPORT ADDED. 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.
THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WANG Y, ZHOU C, YIN H, SONG D. COMPARISON OF CEMENT-AUGMENTED PEDICLE SCREW AND CONVENTIONAL PEDICLE SCREW FOR THE TREATMENT OF LUMBAR DEGENERATIVE PATIENTS WITH OSTEOPOROSIS. EUR J ORTHOP SURG TRAUMATOL. 2024 APR;34(3):1609-1617. DOI: 10.1007/S00590-024-03849-2. EPUB 2024 FEB 16. PMID: (B)(6). OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS RETROSPECTIVE COHORT STUDY IS TO COMPARE THE SAFETY AND CLINICAL EFFICACY BETWEEN USING CEMENT-AUGMENTED PEDICLE SCREWS (CAPS) AND CONVENTIONAL PEDICLE SCREWS (CPS) FOR THE TREATMENT OF LUMBAR DEGENERATIVE PATIENTS WITH OSTEOPOROSIS. THE DATA OF 131 LUMBAR DEGENERATIVE PATIENTS WITH OSTEOPOROSIS WHO WERE TREATED WITH SCREW FIXATION FROM MAY 2016 TO DECEMBER 2019 WERE RETROSPECTIVELY ANALYZED IN THIS STUDY. THE PATIENTS WERE DIVIDED INTO THE FOLLOWING TWO GROUPS ACCORDING TO THE TYPE OF SCREW USED: (I) THE CAPS GROUP (N=85); AND (II) THE CPS GROUP (N=46). THE CAPS GROUP COMPRISED THREE MEN AND 82 WOMEN WITH A MEAN AGE OF 69.22 ± 7.86 YEARS, AND A MEAN FOLLOW-UP PERIOD OF 35.18±6.06 MONTHS. CPS GROUP COMPRISED THREE MEN AND 43 WOMEN WITH A MEAN AGE OF 67.83±6.05 YEARS, AND A MEAN FOLLOW-UP PERIOD OF 37.22±6.24 MONTHS. RELEVANT DATA WERE COMPARED BETWEEN TWO GROUPS, INCLUDING THE DEMOGRAPHICS DATA, CLINICAL RESULTS AND COMPLICATIONS. IN CAPS GROUP, THE SCREWS (VIPER CORTICAL FIX FENESTRATED SCREW SYSTEM, DEPUY SYNTHES,USA) WERE INSERTED INTO THE PLANNED SEGMENTS, AND APPROXIMATELY 1.5¿2 ML OF POLYMETHYLMETHACRYLATE (PMMA) (VERTECEM V+CEMENT, DEPUY SYNTHES, USA) WAS THEN INJECTED INTO THE SPINE VERTEBRA UNDER FUOROSCOPY; THE INJECTION WAS STOPPED IF ANY CEMENT LEAKAGE OCCURRED. IN THE CPS GROUP, THE CONVENTIONAL SCREWS (EXPEDIUM PEDICLE SCREW SYSTEM, DEPUY SYNTHES, USA) WERE INSERTED WITHOUT PMMA INJECTION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SPINE VIPER CORTICAL FIX FENESTRATED SCREW SYSTEM, DEPUY SPINE EXPEDIUM PEDICLE SCREW SYSTEM, AND SYNTHES SPINE VERTECEM V+CEMENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SPINE VIPER CORTICAL FIX FENESTRATED CONSTRUCTS (QTY 31) 6 PATIENTS HAD ADJACENT VERTEBRAL FRACTURES. PERCUTANEOUS VERTEBROPLASTY (PVP) SURGERY WAS PERFORMED IN FOUR OF THE SIX PATIENTS. IN 21 PATIENTS, A SIGNIFICANT INCREASE IN INTERVERTEBRAL DISK SPACE HEIGHT AND A SIGNIFCANT DECREASE IN THE TAILLARD INDEX WERE OBSERVED AFTER THE OPERATION, NO INTERVENTION WAS NOTED. 1 PATIENT WITH A SUPERFICIAL INFECTION, WHICH WAS SUCCESSFULLY TREATED BY SURGICAL DEBRIDEMENT. IN 3 PATIENTS, WHO HAD CSF LEAKAGE, ONE DEVELOPED A WOUND INFECTION AND WAS CURED BY ANTIBIOTICS AND LUMBAR DRAINAGE, AND TWO WERE CURED BY SIMPLE CONSERVATIVE TREATMENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS- VIPER CORTICAL FIX FENESTRATED (QTY 4) 4/384 CEMENTED SCREWS LOOSENING WERE OBSERVED, NO INTERVENTION WAS NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: EXPEDIUM (QTY 16) 1 PATIENT HAD ADJACENT VERTEBRAL FRACTURES. PERCUTANEOUS VERTEBROPLASTY (PVP) SURGERY WAS PERFORMED. IN 14 PATIENTS, A SIGNIFCANT INCREASE IN INTERVERTEBRAL DISK SPACE HEIGHT AND A SIGNIFCANT DECREASE IN THE TAILLARD INDEX WERE OBSERVED AFTER THE OPERATION. 1 PATIENT WITH A WOUND INFECTION NO INTERVENTION WAS NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM (QTY 16) 15/214 SCREWS LOOSENING WERE OBSERVED, NO INTERVENTION WAS NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BIOMATERIAL - CEMENT: VERTECEM V+ (QTY (B)(4)) 25 SCREWS (25/384, 6.51%) HAD CEMENT LEAKAGE, NO INTERVENTION WAS NOTED BUT THE ARTICLE STATED THAT THE INJECTION WAS STOPPED IF ANY CEMENT LEAKAGE OCCURRED DURING THE PROCEDURE. THE CEMENT LEAKAGE MOST FREQUENTLY OCCURRED IN THE PERI VERTEBRAL VENOUS AND WAS CLASSIFIED USING YEOM CLASSIFCATION SYSTEM AS FOLLOWS: TYPE C (2 SCREWS), TYPE B (0 SCREW), TYPE S (23 SCREWS). THE NUMBER OF THE CEMENT LEAKAGE CASES WAS NOT ASSOCIATED WITH BMD OR PREOPERATIVE DIAGNOSIS. THERE WERE NO SERIOUS COMPLICATIONS DUE TO CEMENT LEAKAGE, SUCH AS NERVE INJURY, VASCULAR DAMAGE, OR SYMPTOMATIC PULMONARY EMBOLISM. 3 PATIENTS IN CAPS GROUP WITH CSF LEAKAGE (OF THESE THREE PATIENTS, ONE DEVELOPED A WOUND INFECTION AND WAS CURED BY ANTIBIOTICS AND LUMBAR DRAINAGE, AND TWO WERE CURED BY SIMPLE CONSERVATIVE TREATMENT). 2 PATIENTS IN CPS GROUP HAD CSF LEAKAGE, NO INTERVENTION WAS NOTED BUT THE ARTICLE STATED THAT THE INJECTION WAS STOPPED IF ANY CEMENT LEAKAGE OCCURRED DURING THE PROCEDURE. THIS REPORT INVOLVES ONE UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM. THIS IS REPORT 4 OF 4 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 760859 | UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM | ORTHOSIS, SPINAL PEDICLE FIXATION | MNI | MEDOS INTERNATIONAL SÃ RL CH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |