PLATE, FIXATION, BONE
Report
- Report Number
- 8030965-2018-54968
- Event Type
- Injury
- Date Received
- July 12, 2018
- Report Date
- June 14, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PATIENTS (12 MALES AND 9 FEMALES) WITH MEAN AGE OF 37.1 YEARS (RANGE, 21-53 YEARS). DATE OF EVENT: UNKNOWN. IMPLANT DATE: UNKNOWN. EXPLANT DATE: UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. [(B)(4)].
THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LIU, H. ET AL (2017), SURGICAL MANAGEMENT OF HAWKINS TYPE III TALAR NECK FRACTURE THROUGH THE APPROACH OF MEDIAL MALLEOLAR OSTEOTOMY AND MINI-PLATE FOR FIXATION, JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH, VOL. 12(111), PAGES 1-9 (CHINA). THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO INVESTIGATE THE SURGICAL TREATMENT STRATEGY OF HAWKINS TYPE III TALAR NECK FRACTURES THROUGH APPROACH OF MEDIAL MALLEOLAR OSTEOTOMY AND MINI-PLATE FOR FIXATION AND TO ASSESS THE THERAPEUTIC EFFECTS AFTER LONG-TERM FOLLOW-UP. BETWEEN JANUARY 2010 AND JANUARY 2015, 21 PATIENTS (12 MALES AND 9 FEMALES) WITH MEAN AGE OF 37.1 YEARS (RANGE, 21-53 YEARS) UNDERWENT MEDIAL MALLEOLAR OSTEOTOMY AND MINI-PLATE FIXATION. THE INJURED CHONDRAL SURFACE AND FRACTURE WAS FIXED USING UNKNOWN SYNTHES MINI-SCREWS AND UNKNOWN SYNTHES MINI-PLATE. HAWKINS SCORE CONSISTS OF THREE PARTS: PAIN, THE PRESENCE OF A LIMP, AND RANGE OF MOTION OF THE ANKLE. PAIN WAS ASSIGNED FROM 0 T0 6 POINTS: NO PAIN AS 6 POINTS, PAIN ONLY AFTER FATIGUE AS 3 POINTS, AND PAIN AFTER WALKING AS 0 POINT. THE PRESENCE OF LIMP RANGED FROM 0 TO 3 POINTS: 3 POINTS FOR NO LIMP AND 0 POINT FOR THE PRESENCE OF A LIMP. THE RANGES OF MOTION OF THE ANKLE AND SUBTALAR JOINT WERE RATED FROM 0 T0 3 POINTS, RESPECTIVELY: FULL MOTION AS 3 POINTS, PARTIAL MOTION AS 2 POINTS, AND THE FIXED DEFORMITY AS 0 POINT. OVERALL, ¿EXCELLENT¿ WAS CLASSIFIED AS A CUMULATIVE SCORE OF 13 TO 15, ¿GOOD AS 10 TO 12, ¿FAIR¿ AS 7 TO 9 AND ¿POOR¿ AS 6 OR LESS. THE AMERICAN ORTHOPAEDIC FOOT AND ANKLE SOCIETY (AOFAS) ANKLE-HINDFOOT SCORE WAS ALSO USED TO ASSESS FUNCTIONAL OUTCOME. THE FUNCTIONAL RESULTS WERE OBTAINED REGULARLY POSTOPERATIVELY. FOLLOW-UP WAS CONDUCTED BETWEEN 18 AND 41 MONTHS POST-OPERATION, WITH AN AVERAGE OF 29.6 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED: MEAN VAS SCORE OF 3.2±1.1; MEAN HAWKINS SCORE OF 11.4±3.4. AVERAGE AOFAS HIND FOOT SCORE OF 79.8 ± 17.3; AVASCULAR NECROSIS (AVN); COMPLETE AVN OF THE TALAR BONES; PARTIAL AVN OF THE TALAR BONES. SUPERFICIAL INFECTIONS; PARTIAL WOUND DEHISCENCE; MALUNION ; TALOCRURAL ARTHRITIS; SUBTALAR ARTHRITIS; TALONAVICULAR ARTHRITIS; MALUNION, SECONDARY SURGERY WHERE A PEDICLED PERIOSTEUM FLAP COVERAGE WAS PERFORMED ; ARTHRITIS, SECONDARY SURGERY AND RECEIVED SUBTALAR ARTHRODESIS; ARTHRITIS, SECONDARY SURGERY AND RECEIVED ANKLE ARTHRODESIS; ARTHRITIS, SECONDARY SURGERY AND RECEIVED TOTAL ANKLE REPLACEMENT ; FAIR AOFAS ANKLE-HINDFOOT SCORE CUMULATIVE SCORE ; POOR AOFAS ANKLE-HINDFOOT SCORE CUMULATIVE SCORE. THIS REPORT IS FOR AN UNKNOWN SYNTHES MINI-PLATE. THIS IS REPORT 1 OF 6 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 524216 | PLATE, FIXATION, BONE | HRS | OBERDORF SYNTHES PRODUKTIONS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |