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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW; SCREW, FIXATION, BONE

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BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW; SCREW, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930)
Event Date 05/17/2019
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).Medical product: zimmer biomet tmj system right narrow mandibular component, 45 mm catalog #: 01-6545, lot #: 859610a; zimmer biomet tmj system left narrow mandibular component, 45 mm catalog#: 01-6546, lot#: 787750c; zimmer biomet tmj system right fossa component, small catalog#: 24-6562, lot#: 857280b; zimmer biomet "2.4 mm" system high torque (ht) cross-drive screw catalog#: 91-2708, lot#: ni; zimmer biomet tmj system left fossa component, small catalog#: 24-6563, lot#: 882250c; zimmer biomet tmj system cross drive emergency fossa screw catalog#: 99-6587, lot#: ni; zimmer biomet tmj system cross drive fossa screw catalog#: 99-6577, lot#: ni; zimmer biomet "2.4 mm" system high torque (ht) cross-drive screw catalog#: 91-2710, lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00318, 0001032347-2019-00319, 0001032347-2019-00320, 0001032347-2019-00321, 0001032347-2019-00322, 0001032347-2019-00323, 0001032347-2019-00324, and 0001032347-2019-00325.
 
Event Description
It was reported that the patient developed a hematoma and infection postoperatively.As a result, the implants were removed eleven days after implantation.No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.As a revision occurred, the complaint is confirmed.Functional testing and inspections could not be performed due to the parts not being returned and no photographs, x-rays, ct scans, or physician reports being provided.The dhrs for the screws could not be reviewed due to the lot numbers being unknown.There are no indications of manufacturing defects.For all 2.0x7mm fossa x-dr scrw (part# 99-6577) in the previous year (from the notification date), there is a complaint rate of 0.34%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint cannot be determined.There are no indications of manufacturing defects.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.
 
Event Description
This follow-up report is being submitted to relay additional information.
 
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Brand Name
TMJ SYSTEM CROSS DRIVE FOSSA SCREW
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key8692594
MDR Text Key147779780
Report Number0001032347-2019-00324
Device Sequence Number1
Product Code JEY
UDI-Device Identifier00841036057442
UDI-Public00841036057442
Combination Product (y/n)N
PMA/PMN Number
K910038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 08/19/2019
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number99-6577
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/13/2019
Initial Date FDA Received06/12/2019
Supplement Dates Manufacturer Received08/15/2019
Supplement Dates FDA Received08/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age11 YR
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