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INMODE LTD MORPHEUS8; GEI Back to Search Results
Model Number AG607401A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Peripheral Nervous Injury (4414)
Event Type  Injury  
Manufacturer Narrative
It is likely that the temporary injury to the marginal mandibular nerve was caused during the maneuver of the nerve block administered in the mandibular area near the course of the affected nerve.The actual ability of frf to damage the mandibular nerve are negligible considering the mode of penetration of the needles, the depth of action and the fact that we have never had a similar case, having a history of hundreds of thousands of treatments with m8 investigation conclusions: the administration of a nerve block at the mandibular level would in all likelihood have generated a temporary injury to the marginal mandibular nerve as a neurapraxia.
Event Description
Mandibular nerve palsy on right side post morpheus8 treatment most probably due to the administration of nerve block.
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Brand Name
Type of Device
Manufacturer (Section D)
tavor building (pob 533)
shaar yokneam
yokneam northern, north 20692 06
IS  2069206
Manufacturer (Section G)
tavor building (pob 533)
shaar yokneam
yokneam northern, north 20692 06
IS   2069206
Manufacturer Contact
eran krieger
tavor building (pob 533)
shaar yokneam
yokneam northern, north 20692-06
IS   2069206
MDR Report Key16387088
MDR Text Key309670888
Report Number3010511300-2023-00074
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Administrator/Supervisor
Remedial Action Patient Monitoring
Type of Report Initial,Followup
Report Date 07/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberAG607401A
Device Catalogue NumberAG607401A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2022
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age51 YR
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite