UNK - SCREWS: EXPEDIUM VERSE
Report
- Report Number
- 1526439-2025-01148
- Event Type
- Malfunction
- Date Received
- September 9, 2025
- Date of Event
- December 30, 2024
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL CH
- Product Code
- NKB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.
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: H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. 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: TAKAHASHI S, SAKAI D, OGASAWARA S, SASAKI R, UEMATSU M, HYAKUMACHI T, HIYAMA A, KATOH H, TERAI H, SUZUKI A, TAMAI K, NAKAMURA H, YAGI M. THE RISK OF INTRAVENOUS CEMENT LEAKAGE AND SHORT-TERM OUTCOMES OF SELECTIVE CEMENT-AUGMENTED PEDICLE SCREWS: A MULTICENTER RETROSPECTIVE STUDY. CLIN SPINE SURG. 2025 AUG 1;38(7):E419-E424. DOI: 10.1097/BSD.0000000000001757. EPUB 2024 DEC 30. PMID: 39787382. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS RETROSPECTIVE COHORT STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF CAPS FIXATION EXCLUSIVELY AT THE MOST CEPHALAD AND CAUDAD VERTEBRAL BODIES. THIS STUDY INCLUDED 65 PATIENTS (51 FEMALES; WITH A MEAN AGE OF 75.5 [9.2] YEARS) WHO UNDERWENT SPINAL SURGERY FOR THORACIC OR LUMBAR DISORDERS USING CAPS FIXATION. FOUR CAPSS WERE USED IN EACH PATIENT, AND 254 CAPSS WERE INCLUDED IN THE ANALYSIS. A TOTAL OF 254 CAPS FIXATION PROCEDURES WERE PERFORMED. OF THE 65 PATIENTS, 9 WERE LOST TO FOLLOW-UP WITHIN 3 MONTHS AFTER SURGERY. CHANGES IN CLINICAL AND RADIOLOGIC FINDINGS WERE ANALYZED IN 56 PATIENTS WHO UNDERWENT 230 CAPS FIXATION PROCEDURES. THE SURGICAL PROCEDURE INVOLVED THE USE OF THE EXPEDIUM VERSE SPINAL SYSTEM AND VERTECEM V + CEMENT (DEPUY SYNTHES PRODUCTS, INC.). FOLLOW-UP PERIOD WAS 10.6 (6.3) MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SYNTHES EXPEDIUM VERSE SPINAL SYSTEM AND VERTECEM V+ CEMENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: EXPEDIUM VERSE (QTY 7). - 3 PATIENTS HAD PJK (PROXIMAL JUNCTIONAL KYPHOSIS). NO INTERVENTION INDICATED. - 4 PATIENTS HAD DJK (DISTAL JUNCTIONAL KYPHOSIS). NO INTERVENTION INDICATED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - SCREWS: EXPEDIUM VERSE (QTY 20). - 4 PATIENTS HAD SCREW LOOSENING. NO INTERVENTION INDICATED. - 8 SCREWS OUT OF 230 SCREWS HAD SCREW LOOSENING OCCURRED. NO INTERVENTION INDICATED. - 8 SCREWS OUT OF 204 SCREWS HAD SCREW LOOSENING WAS OBSERVED ON PATIENTS WITHOUT OSTEOPOROSIS. NO INTERVENTION INDICATED BUT EXCLUDED IN THE STUDY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BIOMATERIAL - CEMENT: VERTECEM V+ (QTY 48). - 24 PATIENTS HAD ASYMPTOMATIC AND SYMPTOMATIC INTRAVENOUS CEMENT LEAKAGE WERE OBSERVED. 40 CAPS (CEMENT-AUGMENTED PEDICLE SCREW) FIXATION PROCEDURES AND 2 PATIENTS [3.1%; 2 CAPS (CEMENT-AUGMENTED PEDICLE SCREW) FIXATION PROCEDURES. - 1 PATIENT HAD CEMENT LEAKAGE INTO THE INFERIOR VENA CAVA. REQUIRED AN ADDITIONAL PROCEDURE THROUGH CATHETERIZATION. CT REVEALED NO EVIDENCE OF A PULMONARY EMBOLISM. - 1 PATIENT HAD HYPOTENSION DUE TO INTRAVENOUS CEMENT LEAKAGE AFTER CEMENT INJECTION. SHOWED NO ADVERSE HEALTH EFFECTS POSTOPERATIVELY. CT REVEALED NO EVIDENCE OF A PULMONARY EMBOLISM. - 22 PATIENTS WITHOUT OSTEOPOROSIS HAD CEMENT LEAKAGE WAS OBSERVED. NO INTERVENTION INDICATED BUT EXCLUDED IN THE STUDY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - BIOMATERIAL - CEMENT: VERTECEM V+ (QTY 1). - 67-YEAR-OLD WOMAN HAD CEMENT LEAKAGE WAS OBSERVED AT THE UIV DURING SURGERY. CEMENT INJECTION WAS HALTED. AN AXIAL-VIEW CT SCAN OBTAINED IMMEDIATELY AFTER SURGERY REVEALED INTRAVENOUS CEMENT LEAKAGE WHEREAS A 3-DIMENSIONAL (3D) RECONSTRUCTION OF THE CT SCAN ALSO SHOWED CEMENT LEAKAGE. AN AXIAL-VIEW CT SCAN OBTAINED ONE YEAR AFTER SURGERY SHOWED NO CHANGE IN THE SHAPE OR LOCATION OF THE INTRAVENOUS CEMENT LEAKAGE, WHICH WAS CONFIRMED IN THE 3D RECONSTRUCTION OF THE CT SCAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2841775 | UNK - SCREWS: EXPEDIUM VERSE | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | MEDOS INTERNATIONAL SÃ RL CH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |