UNKNOWN TRAUMA
Received Aug 18, 2016
Report 0001825034-2016-03147 · MDR key 5885738
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WERE NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. (B)(6).
Description of Event or Problem
INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "BALL-JOINT VERSUS SINGLE MONOLATERAL EXTERNAL FIXATORS FOR DEFINITIVE TREATMENT OF TIBIAL SHAFT FRACTURES" WHICH AIMED TO COMPARE A SINGLE, RIGID, MONOLATERAL EXTERNAL FIXATOR WITHOUT BALL-JOINTS WITH A MODULAR, LESS RIGID MONOLATERAL EXTERNAL FIXATOR WITH BALLJOINTS FOR THE TREATMENT OF OPEN AND COMPLEX TIBIAL SHAFT FRACTURES. IN THE ARTICLE, TWO PATIENTS WERE IDENTIFIED AS EXPERIENCING MALUNION. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.