OBERDORF SYNTHES PRODUKTIONS GMBH 3.0MM HEADLESS COMPRESSION SCREW-SHORT THREAD 20MM; SCREW, FIXATION, BONE
|
Back to Search Results |
|
Model Number 02.226.020 |
Device Problem
Unintended Movement (3026)
|
Patient Problems
Failure of Implant (1924); Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
Patient weight is unknown.Date of event: unknown.Implant date: unknown.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.
|
|
Event Description
|
It was reported that a patient was implanted with a 3.0 mm headless compression screw and three (3) other unknown synthes screws on an unknown date at the first proximal phlange.Patient complained of pain on an unknown date along noticeable visibility of the screw pressing upon the skin.X-rays were taken on an unknown date showing one of the four screws backing out.Patient underwent surgery on (b)(6) 2018 to remove the one screw that was backing out.The screw was removed easily.The other three (3) screws had no issues and remained intact.Routine intraoperative x-rays were taken.The patient was not revised to any additional hardware and had achieved union.There was no surgical delay.The procedure was completed successfully and the patient was reported as stable.Concomitant devices reported: unknown synthes screws (part unknown, lot unknown, quantity 3).This is report 1 of 1 for (b)(4).
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|