SUPINE TABLE ATTACHMENT (A2) W/PAD
Received Mar 16, 2021 · Event occurred Feb 23, 2021
Report 3003604053-2021-00093 · MDR key 11499362
Device
Product problems
- Break
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE (B)(4). H10: THE INFORMATION RECEIVED BY THE MANUFACTURER HAS BEEN RE-EVALUATED FOR MDR REPORTING AND IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. ADDITIONAL INFORMATION RECEIVED STATES THAT THE INITIAL MALFUNCTION REPORTED DID NOT CAUSE ANY LOSS OF TRACTION AND THEREFORE THERE WAS NO PATIENT HARM. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING HIP LABRAL REPAIR SURGERY, THE "HIP SUPINE TABLE ATTACHMENT" BROKE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, THE "HIP SUPINE TABLE ATTACHMENT" BROKE. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED OR IF THERE WAS ANY DELAY BUT THEY WERE ABLE TO GET THROUGH THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.