PLATE, FIXATION, BONE
Report
- Report Number
- 3025141-2025-00266
- Event Type
- Injury
- Date Received
- July 14, 2025
- Report Date
- July 14, 2025
- Manufacturer
- ACUMED, LLC
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- 003
Narratives
THE DEVICE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE INFORMATION IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. BELOW ARE ALL RELATED REPORT NUMBERS REGARDING THIS LITERATURE REVIEW (4 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 3025141-2025-00265, 3025141-2025-00267, 3025141-2025-00268.
DURING A LITERATURE REVIEW, IN THE FOLLOWING ARTICLE CITED, "SHIBUYA R, UEDA K, YAMAMOTO S, FUJI T. RELATIONSHIP AMONG POSTOPERATIVE ARTHRITIS, ISCHEMIC CHANGES IN SUBCHONDRAL BONE ON POSTOPERATIVE MR IMAGES, AND CENTRAL IMPACTION FRAGMENT ON PREOPERATIVE COMPUTED TOMOGRAPHY SCANS IN PATIENTS WITH INTRA-ARTICULAR DISTAL RADIUS FRACTURE: A PRELIMINARY REPORT. JOURNAL OF HAND SURGERY GLOBAL ONLINE. 2025 MAY;7(3):100695. DOI: 10.1016/J.JHSG.2025.01.004. PMID: 40496414; PMCID: PMC12147592." THIS RETROSPECTIVE INVESTIGATION STUDY EXAMINED WHETHER OSTEOARTHRITIS (OA) AFTER INTRA-ARTICULAR DISTAL RADIUS FRACTURES (DRF) COULD BE EVALUATED MORE PRECISELY BY COMBING INFORMATION FROM MRI WITH THAT FROM PLAIN RADIOGRAPHS AND CT SCANS, SIMILAR AS TO THE APPROACH WITH HIP AND KNEE JOINTS. BETWEEN APRIL 2010 AND JANUARY 2023, 57 CONSECUTIVE PATIENTS UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION (ORIF) FOR DRFS. BEFORE SURGERY, POSTEROANTERIOR, LATERAL, AND OBLIQUE RADIOGRAPHS OF THE INJURED AND UNINJURED WRISTS WERE OBTAINED. ORIF USING VLPS (42 FOR SMARTLOCK STRYKER, 5 FOR VA-LCP VOLAR DEPUY SYNTHES, 4 FOR ACU-LOC ACUMED AND 6 FOR STELLA HOYA) WAS PERFORMED. TWELVE PATIENTS WITH EXTRAARTICULAR DRFS HAD PROXIMALLY POSITIONED PLATES, AND 45 PATIENTS WITH INTRA-ARTICULAR DRFS HAD DISTALLY POSITIONED PLATES. TWO PATIENTS MOVED TO A DISTANT LOCATION, AND ONE PATIENT DIED OF A STROKE 6 MONTHS AFTER SURGERY FOR THE DRF. THUS, THREE PATIENTS WERE LOST TO FOLLOW-UP. THEREFORE, 54 PATIENTS IN ALL WERE FOLLOWED UP FOR MORE THAN 1 YEAR AFTER SURGERY. OF THE 54 PATIENTS, 16 (12 WITH A PROXIMALLY POSITIONED PLATE AND 4 WITH A DISTALLY POSITIONED PLATE) DID NOT REQUEST HARDWARE REMOVAL. THEREFORE, THEY WERE EXCLUDED FROM THE CURRENT STUDY. THE REMAINING 38 PATIENTS REQUESTED ROUTINE REMOVAL OF HARDWARE NOT DUE TO COMPLICATIONS. BONE FUSION WAS ASSESSED USING CT PRIOR TO HARDWARE REMOVAL. FOR ALL PATIENTS, 3 PATIENTS HAD OSTEOARTHRITIS GRADE 2 AND 1 PATIENT HAD GRADE 3. THE METHODS WERE : INTRA-ARTICULAR DRFS WERE TREATED USING A VOLAR LOCKING PLATE. PLAIN RADIOGRAPHS, COMPUTED TOMOGRAPHY (CT) SCANS, AND POSTOPERATIVE MRI OF 35 PATIENTS WERE EXAMINED. THE MEAN FOLLOW-UP PERIOD WAS 2 YEARS (RANGE, 1-3.5 YEARS). OA WAS CLASSIFIED INTO FOUR GRADES BASED ON PLAIN RADIOGRAPHS AND CT SCAN. CORONAL T1W MRI WAS USED TO MEASURE THE WIDTH OF THE LOW SIGNAL INTENSITY AREA (LSIA) OF THE SUBCHONDRAL BONE. T2W AND SHORT TAU INVERSION RECOVERY (STIR) MRI WERE ALSO EVALUATED. THE AUTHORS CONCLUDED THAT IN INTRA-ARTICULAR DRFS, THE MRI RESULTS SUGGESTED THAT THE SIZE OF THE AREA SHOWING ISCHEMIC CHANGES IN THE SUBCHONDRAL BONE AFFECTS POSTOPERATIVE OA AND THAT THE PRESENCE OF A CENTRAL IMPACTION FRAGMENT MAY FACILITATE THE EXPOSURE OF THE SUBCHONDRAL BONE TO ISCHEMIA. THERE WAS A STRONG RELATIONSHIP BETWEEN THE PRESENCE OF A CENTRAL IMPACTION FRAGMENT AND ISCHEMIC CHANGE IN SUBCHONDRAL BONE AND POSTOPERATIVE OSTEOARTHRITIS. NO OTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1419716 | PLATE, FIXATION, BONE | HRS | ACUMED, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |