NA 298.803SRecalls & reported problems
Synthes GmbH · 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes cerclage positioning pin is an implant used for bone fixation. The 24 reports mostly describe infections, fractures that healed slowly or not at all, and implant failure; they include 24 injuries and no deaths. No recalls name this device, and reports rose from 0 in the previous 12 months to 3 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982182531), received between May 4, 2018 and Nov 11, 2025 — classified as 24 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem24
- No Apparent Adverse Event2
Patient problems
- Unspecified Infection11
- Nonunion/Delayed-union Bone Fracture8
- Bone Fracture(s)4
- Failure of Implant4
- No Code Available4
- Impaired Healing2
- Pain1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6), AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. A TOTAL OF 13 COMPLICATIONS HAVE BEEN REPORTED ACROSS 10 PATIENTS. SEVEN OF THESE LED TO REVISION OR REOPERATION SURGERIES, WITH TWO CASES CONSIDERED DEVICE RELATED¿SPECIFICALLY DUE TO ADVERSE TISSUE REACTION AND TROCHANTERIC BURSITIS. THE REMAINING REVISIONS WERE ASSOCIATED WITH PAIN, INFECTION, NONUNION, SEPSIS, AND HARDWARE PROMINENCE. OTHER REPORTED COMPLICATIONS INCLUDE POST-OPERATIVE AND INTRA-OPERATIVE FRACTURES, SUPERFICIAL INFECTION, AND ONE DEATH DUE TO NATURAL CAUSES. SUBJECT (B)(6), 45-YEAR-OLD FEMALE. PATIENT EXPERIENCED OSTEOMYELITIS REMOVAL OF IMPLANTS AND CONVERSION TO THA.
Patient problems: Unspecified Infection
MAUDE report 23525683 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HOSPITAL AND (B)(6), AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. A TOTAL OF 13 COMPLICATIONS HAVE BEEN REPORTED ACROSS 10 PATIENTS. SEVEN OF THESE LED TO REVISION OR REOPERATION SURGERIES, WITH TWO CASES CONSIDERED DEVICE RELATED¿SPECIFICALLY DUE TO ADVERSE TISSUE REACTION AND TROCHANTERIC BURSITIS. THE REMAINING REVISIONS WERE ASSOCIATED WITH PAIN, INFECTION, NONUNION, SEPSIS, AND HARDWARE PROMINENCE. OTHER REPORTED COMPLICATIONS INCLUDE POST-OPERATIVE AND INTRA-OPERATIVE FRACTURES, SUPERFICIAL INFECTION, AND ONE DEATH DUE TO NATURAL CAUSES. SUBJECT NUMBER (B)(4), 45-YEAR-OLD FEMALE. PATIENT EXPERIENCED OSTEOMYELITIS REQUIRING IRRIGATION AND DEBRIDEMENT.
Patient problems: Unspecified Infection
MAUDE report 23524060 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6), AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. A TOTAL OF 13 COMPLICATIONS HAVE BEEN REPORTED ACROSS 10 PATIENTS. SEVEN OF THESE LED TO REVISION OR REOPERATION SURGERIES, WITH TWO CASES CONSIDERED DEVICE RELATED¿SPECIFICALLY DUE TO ADVERSE TISSUE REACTION AND TROCHANTERIC BURSITIS. THE REMAINING REVISIONS WERE ASSOCIATED WITH PAIN, INFECTION, NONUNION, SEPSIS, AND HARDWARE PROMINENCE. OTHER REPORTED COMPLICATIONS INCLUDE POST-OPERATIVE AND INTRA-OPERATIVE FRACTURES, SUPERFICIAL INFECTION, AND ONE DEATH DUE TO NATURAL CAUSES. SUBJECT (B)(6), 45-YEAR-OLD FEMALE. PATIENT EXPERIENCED PAIN REQUIRING REVISION. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2021.
Patient problems: Pain
MAUDE report 23523526 ↗InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2019 DUE TO INFECTION. THIS COMPLAINT INVOLVES TWENTY FOUR (24) DEVICE ONLY. THIS COMPLAINT (B)(4) REPORTS FOUR (4) DEVICES, REMAINING 20 DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15685670 ↗InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2019 DUE TO INFECTION. THIS COMPLAINT INVOLVES TWENTY FOUR (24) DEVICE ONLY. THIS COMPLAINT (B)(4) REPORTS FOUR (4) DEVICES, REMAINING 20 DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15685616 ↗InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2019 DUE TO INFECTION. THIS COMPLAINT INVOLVES TWENTY FOUR (24) DEVICE ONLY. THIS COMPLAINT (B)(4) REPORTS FOUR (4) DEVICES, REMAINING 20 DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4) . THIS REPORT IS FOR ONE (1) 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15685611 ↗InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS REVISED ON (B)(6) 2019 DUE TO INFECTION. THIS COMPLAINT INVOLVES TWENTY FOUR (24) DEVICE ONLY. THIS COMPLAINT (B)(4) REPORTS FOUR (4) DEVICES, REMAINING 20 DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15685609 ↗InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019 PATIENT WAS REVISED DUE TO INFECTION. CONCOMITANT DEVICE REPORTED: ALTRX NEUT 36IDX58OD(122136058/J2653A) APEX HOLE ELIM (124603000/D18101698) PINN CUP 58MM (121722058/J21N76) BONE SCREW 6.5MMX45MM (121745500/D18051131) THIS REPORT IS FOR ONE (1)4.5 THRD CERCLAGE POSITIONING PIN-SILE THIS IS REPORT 20 OF 20 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15677891 ↗InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT WAS REVISED DUE TO INFECTION. CONCOMITANT DEVICE REPORTED: ALTRX NEUT 36IDX58OD(122136058/J2653A). APEX HOLE ELIM (124603000/D18101698). PINN CUP 58MM (121722058/J21N76). BONE SCREW 6.5MMX45MM (121745500/D18051131). THIS REPORT IS FOR ONE (1)4.5 THRD CERCLAGE POSITIONING PIN-SILE. THIS IS REPORT 8 OF 20 FOR COMPLAINT (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15677047 ↗InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT WAS REVISED DUE TO INFECTION. CONCOMITANT DEVICE REPORTED: ALTRX NEUT 36IDX58OD(122136058/J2653A). APEX HOLE ELIM (124603000/D18101698). PINN CUP 58MM (121722058/J21N76). BONE SCREW 6.5MMX45MM (121745500/D18051131). THIS REPORT IS FOR ONE (1)4.5 THRD CERCLAGE POSITIONING PIN-SILE. THIS IS REPORT 6 OF 20 FOR COMPLAINT: (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15676033 ↗InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020 PATIENT HAD REPAIR LEFT FEMUR MALUNION/NONUNION WITH AUTO GRAFT AND BONE GRAFTING LEFT FEMORAL HEAD. ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF HARDWARE HIP (LEFT) CONVERSION, PREVIOUS HIP SURGERY TO TOTAL HIP ARTHROPLASTY (LEFT). OPERATIVE FINDINGS WITH NON UNION FAILED TFN, LEFT SUPERIOR ACETABULAR DEFECT. ON (B)(6) 2020 PATIENT HAD UNDERGONE IRRIGATION AND DEBRIDEMENT HIP (LEFT) - PROSTHETIC HIP INFECTION. CONCOMITANT: TRIGEN INTERTAN 11.5MM X 18CM 125DEGREE (PART 71675202 LOT 19LMD7004,QUANTITY#1) INTERTAN LAG/COMPRESSION SCREW KIT 85MM / 80MM (PART 71677085 LOT 17BT8266, QUANTITY#1) TRIGEN (PART71645030 LOT 20320696,QUANTITY#1). THIS REPORT IS FOR ONE (1) 4.5 THRD CERCLAGE POSITIONING PIN-SILE. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection
MAUDE report 15208404 ↗InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020 PATIENT HAD REPAIR LEFT FEMUR MALUNION/NONUNION WITH AUTO GRAFT AND BONE GRAFTING LEFT FEMORAL HEAD. ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF HARDWARE HIP (LEFT) CONVERSION, PREVIOUS HIP SURGERY TO TOTAL HIP ARTHROPLASTY (LEFT). OPERATIVE FINDINGS WITH NON UNION FAILED TFN, LEFT SUPERIOR ACETABULAR DEFECT. ON (B)(6) 2020 PATIENT HAD UNDERGONE IRRIGATION AND DEBRIDEMENT HIP (LEFT) - PROSTHETIC HIP INFECTION. CONCOMITANT : TRIGEN INTERTAN 11.5MM X 18CM 125DEGREE (PART 71675202 LOT 19LMD7004,QUANTITY#1) INTERTAN LAG/COMPRESSION SCREW KIT 85MM / 80MM (PART 71677085 LOT 17BT8266, QUANTITY#1) TRIGEN (PART71645030 LOT 20320696,QUANTITY#1). THIS REPORT IS FOR ONE (1) 4.5 THRD CERCLAGE POSITIONING PIN-SILE THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection
MAUDE report 15208403 ↗InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REVISION SURGERY. DURING THE SURGERY, THE HARDWARE WAS REMOVED FROM THE PATIENT'S FEMUR AND USED RIA TO GET BONE GRAFT FROM OPERATIVE FEMUR DUE TO A NONUNION FROM THE PREVIOUS SURGERY. SURGEON REVISED FEMUR USING A UNIVERSAL FEMORAL NAIL, AND A VA CONDYLAR PLATE. HE THEN PUT IN BONE GRAFT COLLECTED FROM RIA IN THE NONUNION SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S SURGERY WAS REVISED. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR (1) 4.5 THRD CERCLAGE POSITIONING PIN-SILE . THIS REPORT IS 8 OF 14 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12515808 ↗InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REVISION SURGERY. DURING THE SURGERY, THE HARDWARE WAS REMOVED FROM THE PATIENT'S FEMUR AND USED RIA TO GET BONE GRAFT FROM OPERATIVE FEMUR DUE TO A NONUNION FROM THE PREVIOUS SURGERY. SURGEON REVISED FEMUR USING A UNIVERSAL FEMORAL NAIL, AND A VA CONDYLAR PLATE. HE THEN PUT IN BONE GRAFT COLLECTED FROM RIA IN THE NONUNION SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S SURGERY WAS REVISED. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. THIS REPORT IS FOR (1) 4.5 THRD CERCLAGE POSITIONING PIN-SILE. THIS REPORT IS 3 OF 14 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12514251 ↗InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL PROCEDURE, THE PLATE WAS REMOVED DUE TO BONE HEALING FAILURE. THIS WAS IMPLANTED NO (B)(6) 2021. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 4.5 THRD CERCLAGE POSITIONING PIN-SILE. THIS REPORT IS 7 OF 10 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12502434 ↗InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL PROCEDURE, THE PLATE WAS REMOVED DUE TO BONE HEALING FAILURE. THIS WAS IMPLANTED ON (B)(6) 2021. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.7MM CABLE WITH CRIMP 750MM-STERILE. THIS REPORT IS 9 OF 10 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12502399 ↗InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL EVENT DESCRIPTION: ON (B)(6) 2019, A CLINIC REPORTED THAT PATIENT HAD A RECENT FALL, AND SUSTAINED A DISPLACED FRACTURE DISTAL TIP. PAIN LEVEL IS 4/10. ON (B)(6) 2019, PROGRESS NOTE REPORTED THAT A FRACTURE PLATE AT THE SITE OF PREVIOUS FRACTURE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12308357 ↗InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL EVENT DESCRIPTION: ON (B)(6)2019, A CLINIC REPORTED THAT PATIENT HAD A RECENT FALL, AND SUSTAINED A DISPLACED FRACTURE DISTAL TIP. PAIN LEVEL IS 4/10. ON (B)(6)2019, PROGRESS NOTE REPORTED THAT A FRACTURE PLATE AT THE SITE OF PREVIOUS FRACTURE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 12307596 ↗InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, AN ABNORMAL RADIOGRAPHIC EVALUATION OCCURRED. THERE WAS A HARDWARE FAILURE AT THE FRACTURE SITE, AS WELL AS ANGULATION OF THE FRACTURE. ONE (1) CERCLAGE CABLE WITH CRIMP, FOUR (4) THREADED CERCLAGE POSITIONING PIN-STERILE, THREE (3) CABLE WITH CRIMP AND ONE (1) TITANIUM CERCLAGE POSITIONING PIN-STERILE WERE IMPLANTED ON (B)(6) 2019. THE ORIGINAL INDICATION FOR USING THE SYNTHES DEVICES WAS FOR TREATMENT OF AN INTRAOPERATIVE FEMUR FRACTURE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE. THIS IS REPORT 9 OF 9 FOR (B)(4).
Patient problems: Failure of Implant; Impaired Healing; No Code Available
MAUDE report 8674825 ↗InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, AN ABNORMAL RADIOGRAPHIC EVALUATION OCCURRED. THERE WAS A HARDWARE FAILURE AT THE FRACTURE SITE, AS WELL AS ANGULATION OF THE FRACTURE. ONE (1) CERCLAGE CABLE WITH CRIMP, FOUR (4) THREADED CERCLAGE POSITIONING PIN-STERILE, THREE (3) CABLE WITH CRIMP AND ONE (1) TITANIUM CERCLAGE POSITIONING PIN-STERILE WERE IMPLANTED ON (B)(6) 2019. THE ORIGINAL INDICATION FOR USING THE SYNTHES DEVICES WAS FOR TREATMENT OF AN INTRAOPERATIVE FEMUR FRACTURE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A 4.5MM THREADED CERCLAGE POSITIONING PIN-STERILE. THIS IS REPORT 8 OF 9 FOR (B)(4).
Patient problems: Failure of Implant; Impaired Healing; No Code Available
MAUDE report 8674792 ↗InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THIS IS REPORT 3 OF 9 FOR (B)(4).
Patient problems: Bone Fracture(s); Failure of Implant; No Code Available
MAUDE report 8620453 ↗InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THIS IS REPORT 2 OF 9 FOR (B)(4).
Patient problems: Bone Fracture(s); Failure of Implant; No Code Available
MAUDE report 8620450 ↗InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD AN ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PERIPROSTHETIC FRACTURE OF TOTAL HIP STEM ON (B)(6) 2018. A LONG BROAD CURVED PLATE WAS USED WITH CABLES TO FIX THE FRACTURE. PATIENT LATER SUFFERED A NEW FRACTURE DISTAL TO THE PLATE AND THE SURGEON REVISED THE ORIGINAL PLATE BY REMOVING IT AND REPLACING IT WITH A 4.5 VA-LCP CURVED CONDYLAR PLATE AND CABLES ON (B)(6) 2018. THE ORIGINAL CONSTRUCT DID NOT FAIL. IT WAS REMOVED TO REVISE TO A NEW PLATE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT DISPOSITION IS UNKNOWN. THIS REPORT IS FOR A 4.5 THREADED CERCLAGE POSITIONING PIN. THIS IS REPORT 5 OF 10 FOR (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 7487478 ↗InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD AN ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PERIPROSTHETIC FRACTURE OF TOTAL HIP STEM ON (B)(6) 2018. A LONG BROAD CURVED PLATE WAS USED WITH CABLES TO FIX THE FRACTURE. PATIENT LATER SUFFERED A NEW FRACTURE DISTAL TO THE PLATE AND THE SURGEON REVISED THE ORIGINAL PLATE BY REMOVING IT AND REPLACING IT WITH A 4.5 VA-LCP CURVED CONDYLAR PLATE AND CABLES ON (B)(6) 2018. THE ORIGINAL CONSTRUCT DID NOT FAIL. IT WAS REMOVED TO REVISE TO A NEW PLATE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT DISPOSITION IS UNKNOWN. THIS REPORT IS FOR A 4.5 THREADED CERCLAGE POSITIONING PIN. THIS IS REPORT 4 OF 10 FOR (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 7487447 ↗
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- Tritium® Sternal Cable Plate System 86-27-12-S12Pioneer Surgical Technology, Inc. · CERCLAGE, FIXATION1 recall0 reports
- Accord 71340007Smith & Nephew, Inc. · CERCLAGE, FIXATION47 reports
- ZipFix 08.501.001.01SSynthes GmbH · CERCLAGE, FIXATION39 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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