UNK - CONSTRUCTS: VEPTR

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE: RAMIREZ N, ACOSTA JULBE JI, SMITH J, EMANS J, SAMDANI A, ERICKSON M, FLYNN J, TORRES LUGO NJ, CLAUDIO-MARCANO AM, OLIVELLA G; PEDIATRIC SPINE STUDY GROUP. HOW DOES THE VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB LENGTHENING INTERVALS AFFECT THE CLINICAL OUTCOME IN EARLY ONSET SCOLIOSIS PATIENTS? A FIVE-YEAR FOLLOW-UP STUDY. J PEDIATR ORTHOP. 2025 AUG 1;45(7):370-375. DOI: 10.1097/BPO.0000000000002971. EPUB 2025 APR 28. PMID: 40289306. OBJECTIVE/METHODS/STUDY DATA: A RETROSPECTIVE REVIEW CONDUCTED AND DUE TO THE LIMITED INFORMATION ON HOW LENGTHENING INTERVALS AFFECT VEPTR CLINICAL RESULTS, THE STUDY AIMED TO EVALUATE THE CLINICAL OUTCOMES CONCERNING THE LENGTHENING INTERVALS WITHIN A LARGE COHORT OF PATIENTS, MULTIPLE SURGEONS, AND LONGER FOLLOW-UPS. BETWEEN 2000 AND 2023, A TOTAL OF 447 PATIENTS WERE INCLUDED IN THE STUDY. GROUP 1 INCLUDED 158 PATIENTS (78 MALE, 80 FEMALE), WHILE GROUP 2 INCLUDED 289 PATIENTS (150 MALE, 139 FEMALE). PATIENTS UNDERWENT INTERRUPTED THE TRADITIONAL VEPTR INSTRUMENTATION SURGERY. A MINIMUM OF A 5-YEAR FOLLOW-UP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES, VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - CONSTRUCTS: VEPTR (QTY 40). (N=40) CASES OF INFECTION-RELATED COMPLICATIONS (ACCOUNTED FOR 12 CASES IN GROUP 1 AND 28 IN GROUP 2), NO INTERVENTION PROVIDED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - VEPTR IMPLANTS (QTY 127). (N=127) CASES OF DEVICE MIGRATION, (WITH 50 CASES IN GROUP 1 AND 77 IN GROUP 2), NO INTERVENTION PROVIDED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # P(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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.