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

Model Number	BW25G
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Memory Loss/Impairment (1958); Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: WAX,BONE
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8575833
• Report Number: 9615742-2019-01592
• Device Sequence Number: 13998821
• Product Code: MTJ
• UDI-Device Identifier: 10884521196261
• UDI-Public: 10884521196261
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K024372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: BW25G
• Device Catalogue Number: BW25G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 YR