MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS BONE WAX; WAX,BONE

Model Number BW25G

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Memory Loss/Impairment (1958); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: an unusual complication of bone wax utilization source: the journal of craniofacial surgery, volume 29, 2018 (976¿979) article number: 4 date of publication: 16 november 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, patient who initially underwent craniotomy for the evacuation of subdural hematoma and repair of depressed skull fracture, bone wax was migrated intracranially.Postoperatively, patient developed short-term memory loss, apraxia, and word finding difficulties.The imaging findings were consistent with the presence of a foreign body centered in the posterior aspect of the left middle temporal gyrus, which was surgically removed and found to be bone wax.

• Brand Name: BONE WAX
• Type of Device: WAX,BONE
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8575833
• MDR Text Key: 143931948
• Report Number: 9615742-2019-01592
• Device Sequence Number: 1
• Product Code: MTJ
• UDI-Device Identifier: 10884521196261
• UDI-Public: 10884521196261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BW25G
• Device Catalogue Number: BW25G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 05/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR