CORTICAL STABILIZATION SCREW, D=3.0MM, L=18MM, RH
Received Dec 5, 2022 · Event occurred Oct 20, 2022
Report 3004369035-2022-00165 · MDR key 15915712
Device
Generic name
Cortical Stabilization Screw, D=3.0mm, L=18mm, Rh
Manufacturer
I.t.s. GmbhModel number
37304-18Catalog number
37304-18
Lot number
86/435590
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT LOCKING SCREWS DIDN'T LOCK IN A RADIUS PLATE 3-HOLE.
Additional Manufacturer Narrative
WE HAVE INSPECTED THE DHF OF THE AFFECTED LOTS INCLUDING MATERIAL CERTIFICATE AND THE BATCH WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THE ARTICLE MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE VERIFICATION OF THE RETURNED DEVICES SHOWED NO DEVIATIONS. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.