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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM 11.5IN PECTUS SUPPORT BAR; PLATE, FIXATION, BONE

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BIOMET MICROFIXATION PECTUS SYSTEM 11.5IN PECTUS SUPPORT BAR; PLATE, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Foreign Body Reaction (1868); Unspecified Infection (1930)
Event Date 09/14/2020
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2020-00502.Concomitant medical products: pectus system 11.5in pectus support bar, part# 01-3711-05, lot# 227940.Pectus system elongated pectus stabilizer, part# 01-3801, lot# 407190.Occupation: distributor on behalf of facility.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
 
Event Description
It was reported the patient experienced a foreign body reaction and infection twenty-eight (28) days following implantation of a pectus support bar for the treatment of pectus excavatum.The patient was re-admitted to the hospital and received symptomatic supportive treatment.After three (3) days of treatment, the patient¿s temperature had returned to normal and the purulent discharge from the incision was significantly reduced.The situation resulted in an unspecified psychological impact on the patient.No additional patient consequences have been reported.
 
Event Description
This follow-up report is being submitted to relay additional information.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed because of the report of post-operative intervention to preclude serious injury.The device was not returned for investigation as it was reported that the device remains implanted.The treatment described by the sales associate is indicative of an infection rather than a foreign body reaction, which is likely to require explantation of the devices.This is the only complaint for this item# 01-3711-05, lot# 227940.For this part (01-3711-05) in the previous one year (from the notification date) regarding infection, there is a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the infection could not 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.
 
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Brand Name
PECTUS SYSTEM 11.5IN PECTUS SUPPORT BAR
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key10645099
MDR Text Key210371516
Report Number0001032347-2020-00501
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00841036124571
UDI-Public00841036124571
Combination Product (y/n)N
PMA/PMN Number
K972420
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 10/28/2020
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
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number01-3711-05
Device Lot Number227940
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/27/2020
Initial Date FDA Received10/07/2020
Supplement Dates Manufacturer Received10/28/2020
Supplement Dates FDA Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age15 YR
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