• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM ELONGATED PECTUS STABILIZER; PLATE, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET MICROFIXATION PECTUS SYSTEM ELONGATED PECTUS STABILIZER; PLATE, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Edema (1820)
Event Date 09/02/2019
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 reports: 0001032347-2020-00418.Concomitant medical products: pectus system 11in pectus support bar, part# 01-3711, lot# 089450.Pectus system elongated pectus stabilizer, part# 01-3801, lot# 169680.(b)(6).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 was treated for an edema at the incision site and poor wounding healing following implantation of a pectus support bar.After two (2) months of symptomatic treatment, the incision healed and the edema disappeared.No additional patient consequences have been reported.
 
Event Description
It was reported the patient was treated for an edema at the incision site and poor wounding healing seven (7) weeks following implantation of a pectus support bar.After two (2) months of symptomatic treatment, the incision healed and the edema disappeared.No additional patient consequences have been reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following fields were updated: b4 date of this report b5 describe event or problem d6 implantation date g4 date received by manufacturer g7 type of report h2 follow up type h10 additional narratives/data.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed, because it was reported additional treatment was done to resolve the issue.The device was not returned for investigation and no photos, scans, x-rays, or physician's reports were provided.For these reasons, no functional testing or inspections could be performed.The dhr was reviewed; no non-conformances were found.There are no indications of manufacturing defects.For this part (01-3801) in the previous one year (from the notification date) regarding post-operative incision non-union and effusion, there is a complaint rate of 0.05% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint cannot be determined.Possible causes for post-operative incision non-union could include not following proper wound closure techniques, patient condition, or activity level.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PECTUS SYSTEM ELONGATED PECTUS STABILIZER
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key10484890
MDR Text Key206880051
Report Number0001032347-2020-00419
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00841036011093
UDI-Public00841036011093
Combination Product (y/n)N
PMA/PMN Number
K981789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 09/29/2020
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
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number01-3801
Device Lot Number169680
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/25/2020
Initial Date FDA Received09/02/2020
Supplement Dates Manufacturer Received08/30/2020
09/28/2020
Supplement Dates FDA Received09/15/2020
09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Required Intervention;
Patient Age15 YR
-
-