HTR-PMI 990476 RT FRT TEMP PAR
Received Oct 27, 2021 · Event occurred Mar 31, 2021
Report 0001032347-2021-00496 · MDR key 12706355
Device
Generic name
Cranioplasty Plate, Non-alterable
Manufacturer
Biomet MicrofixationModel number
NICatalog number
PM623817-A
Lot number
026970
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
19 YR · Unknown
- Swelling/ Edema
- Swelling/ Edema
Narrative
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative
(B)(4). REPORT SOURCE: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL CRANIOTOMY. SUBSEQUENTLY, APPROXIMATELY (1) DAY POST IMPLANTATION DUE TO A SUDDEN BRAIN SWELLING OF UNKNOWN ORIGIN. THE DEVICE WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.