ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM
Received Jan 28, 2020 · Event occurred Jan 8, 2020
Report 9610612-2019-00927 · MDR key 9638451
Device
Generic name
Mplants Cervical Stabilisatio
Manufacturer
Aesculap AgModel number
FJ933TCatalog number
FJ933T
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Not reported
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
GENERAL INFORMATION POST OPERATIVE INCIDENT. CONSEQUENCES FOR THE PATIENT POST- OPERATIVE MEDICAL INTERVENTION WAS NECESSARY (X- RAY). INVESTIGATION NO PRODUCT AT HAND. BATCH HISTORY REVIEW BECAUSE THE BATCH OF THE PRODUCT IS UNKNOWN, A BATCH HISTORY ANALYSIS IS NOT POSSIBLE. THE DOCUMENTATIONS OF THE IN THE COMPLAINT MENTIONED POSSIBLE LOTS 52511110 AND 52426749 HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. THERE ARE NO COMPLAINTS WITH THE MENTIONED LOTS AT HAND. CONCLUSION AND ROOT CAUSE WITHOUT A PRODUCT AVAILABLE FOR ANALYSIS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MAYBE IT IS POSSIBLE THAT - CAUSED BY A SLIGHTLY DIFFERENT X- RAY ANGLE - IT ONLY APPEARS THAT THE SCREW HAS MOVED OUT. IN THE X- RAY PICTURE, WE SAW THAT THE SLOT HOLES ARE VISIBLE AND THE HEAD OF THE MENTIONED SCREW IS SLIGHTLY COVERED BY THE PLATE. ADDITIONALLY THE PLATE IS X- RAYED IN A 90° ANGLE, THE SLOT HOLES OF THE PLATE ARE NOT VISIBLE. NEVERTHELESS WE AGREE, THAT THE CASE SHOULD BE TAKEN UNDER OBSERVATION. IF WE HAVE ADDITONALLY INFORMATION, WE WILL DO AN UPDATE WITH A SUPPLEMENTAL REPORT. CORRECTIVE ACTION ACCORDING TO SOP (B)(4) (CORRECTIVE ACTION & PREVENTIVE ACTION) A CAPA IS NOT NECESSARY.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH ABC SELF-LOCKING SCREW. FOLLOWING INFORMATION WAS REPORTED: INITIAL CERVICAL POSTERIOR FIXATION SURGERY WAS PERFORMED ON (B)(6) 2019. FOUR SCREWS WERE PLACED; HOWEVER ONE OF THE SCREWS WAS LOOSENING OUT OF THE PLATE IN EARLY (B)(6), AS COULD BE SEEN IN THE X-RAY IMAGE. THE SURGEON STATED THAT HE HAD MADE CERTAIN THE SCREW HEAD WAS FIRMLY LOCKED IN THE PLATE. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE PATIENT REQUIRED PERIODIC MONITORING FOR LOOSENING. A REVISION WAS NOT YET PLANNED. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4).