MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision is planned for a later unspecified date at which time the device may be returned for testing.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00107, 0001032347-2020-00108.Medical products: htr-pmi a.B.1953-20190619 right top parietal implant, part # pm622209, lot # 917120, 1.5mm system 4 hole extra long straight plate, part # 01-7048, lot # unknown, 1.5mm system high torque (ht), sd, x-dr, scr, 5/pk, part # 91-6104, lot # unknown, unknown screws, part # unknown, lot # unknown.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported the patient will undergo a revision of a custom cranial plate due to unspecified medical issues.The custom cranial implant will be removed and will be replaced with a new custom cranial implant.Attempts have been made and no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed as a revision surgery was reported.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The dhr could not be reviewed due to the lot numbers being unknown.There are no indications of manufacturing defects.The most likely underlying cause of the complaint is due to the health condition of the patient.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following fields were updated: b4 date of this report.B5 describe event or problem.D10 device availability.G4 date received by manufacturer.G7 type of report.H2 follow up type.H3 device evaluated by manufacturer.H6 method code.H6 results code.H6 conclusions code.H10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9709341
• Report Number: 0001032347-2020-00109
• Device Sequence Number: 3381211
• Product Code: JEY
• UDI-Device Identifier: 00841036219505
• UDI-Public: 00841036219505
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-6104
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention