UNK - CONSTRUCTS: TITANIUM MESH PLATE AND SCREWS

Report

Report Number: 8030965-2025-00238
Event Type: Injury
Date Received: January 8, 2025
Manufacturer: SYNTHES GMBH
Product Code: HRS
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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.

Description of Event or Problem · 0

THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) FOR PATIENTS TREATED WITH DEPUY SYNTHES LOWER EXTREMITY PLATE SYSTEMS BETWEEN (B)(6) 2000 AND (B)(6) 2023. SUBSEQUENT SURGERY, MALUNION, AND NONUNION HAVE BEEN IDENTIFIED AS THE REPORTED COMPLICATIONS AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES ANGLED BLADE PLATES & SCREWS (QTY 14): 8 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 2 PATIENTS HAD MALUNION AT 0-365 DAYS; 4 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES CALCANEAL PLATES & SCREWS (QTY 12): 3 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 2 PATIENTS HAD MALUNION AT 0-365 DAYS; 7 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES DISTAL FEMUR PLATES & SCREWS (QTY 332):163 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS;11 PATIENTS HAD MALUNION AT 0-365 DAYS;158 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES DISTAL TIBIA PLATES AND SCREWS (QTY 801): 548 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 26 PATIENTS HAD MALUNION AT 0-365 DAYS; 227 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES DYNAMIC COMPRESSION PLATES AND SCREWS (QTY 50): 46 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 4 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES DYNAMIC HIP IMPLANTS (QTY 665): 530 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 14 PATIENTS HAD MALUNION AT 0-365 DAYS; 121 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES FEMORAL NECK SYSTEM (QTY 53): 40 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 4 PATIENTS HAD MALUNION AT 0-365 DAYS; 9 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES FIBULA PLATE SYSTEM (QTY 683): 567 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 22 PATIENTS HAD MALUNION AT 0-365 DAYS; 94 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES HAND AND FOOT PLATES- FOOT PLATES AND SCREWS (QTY 138): 124 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 2 PATIENTS HAD MALUNION AT 0-365 DAYS; 12 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES HAND AND FOOT PLATES - MINI FRAGMENT AND SCREWS (QTY 82): 73 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 1 PATIENTS HAD MALUNION AT 0-365 DAYS; 8 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES LCP HOOK PLATE 3.5 AND SCREWS (QTY 115): 91 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 6 PATIENTS HAD MALUNION AT 0-365 DAYS; 18 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES LOCKING ATTACHMENT PLATE AND SCREWS (QTY 10): 10 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES MESH PLATE & SCREWS SUBGROUP: PATELLA (QTY 7): 5 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 2 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES PATELLA PLATE & SCREWS (QTY 7): 7 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES PEDIATRIC HIP PLATES AND SCREWS (QTY 95): 91 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 1 PATIENT HAD MALUNION AT 0-365 DAYS; 3 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES PELVIC IMPLANTS (QTY 38): 12 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 3 PATIENTS HAD MALUNION AT 0-365 DAYS; 23 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES PERIPROSTHETIC PROXIMAL FEMUR PLATE AND SCREWS (QTY 1): 1 PATIENT HAD SUBSEQUENT SURGERY AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES PROXIMAL FEMORAL PLATES AND SCREWS (QTY 131): 78 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 4 PATIENTS HAD MALUNION AT 0-365 DAYS; 49 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES PROXIMAL TIBIAL PLATES AND SCREWS (QTY 1089): 851 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 36 PATIENTS HAD MALUNION AT 0-365 DAYS; 202 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM AND SCREWS (QTY 27): 18 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS; 5 PATIENTS HAD MALUNION AT 0-365 DAYS; 4 PATIENTS HAD NONUNION AT 0-365 DAYS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH DEPUY SYNTHES VA LCP MEDIAL COLUMN FUSION PLATES AND SCREWS (QTY 2): 2 PATIENTS HAD SUBSEQUENT SURGERY AT 0-365 DAYS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1011696	UNK - CONSTRUCTS: TITANIUM MESH PLATE AND SCREWS	PLATE, FIXATION, BONE	HRS	SYNTHES GMBH

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention