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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB TRAUMA PLATING SYSTEM 2.0 LACTOSORB L- PLATE LEFT REGULAR

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BIOMET MICROFIXATION LACTOSORB TRAUMA PLATING SYSTEM 2.0 LACTOSORB L- PLATE LEFT REGULAR Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Osteolysis (2377)
Event Date 09/08/2017
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4). This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of picture provided. The picture appears to be a fragment of these implants, however no conclusion can be reached as to the identity of this fragment or cause of this complaint due to the poor quality and limited content of the picture. No product was returned and no functional tests or inspections could be performed. No x-rays, scans, physicians reports, or additional pictures were provided. Review of the complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2017-00746-1 through 0001032347-2017-00750-1.
 
Manufacturer Narrative
Zimmer biomet complaint (b)(4). Report source: foreign country: (b)(6). This follow-up report is being submitted to relay additional information. The lot number involved in the event is unable to be confirmed, however the distributor provided potential lots 437670 manufactured july 6, 2016 with a sterile expiration date of july 6, 2021 and 437680 manufactured july 6, 2016 with a sterile expiration date of july 6, 2021. Device history records (dhrs) were reviewed and no discrepancies were found. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2017-00746-3, 0001032347-2017-00747-2, 0001032347-2017-00749-2, and 0001032347-2017-00750-2.
 
Event Description
Additional information was received that the patient is still experiencing swelling again in spite of the revision surgery.
 
Manufacturer Narrative
A photograph of one of the devices was provided. The photograph was reviewed by the research director; he stated, "in looking at the picture, i am not sure of the scale but it appears that if the picture is of one of the l-plates, then the material is resorbing as it is supposed to. " in regards to the osteolysis, he states, "the revision surgery was done with removal of the plate approximately 8 months after implant with the surgeon indicating that there was osteolysis/bone resorption. It is unlikely that the lactosorb material was the source of this because of the very short timeframe after implantation and the fact that the polymer material is biocompatible and is hydrolyzed naturally by the body over time without the creation of wear debris. " the user facility is foreign; therefore a facility medwatch report will not be available. Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. This is report three of five for the same event; reference reports 0001032347-2017-00746 through 0001032347-2017-00750.
 
Event Description
It was reported the original surgery was performed on (b)(6) 2017. Six months post operative, the patient complained of pain in the right maxilla. The surgeon examined the patient and confirmed inflammation. The surgeon treated the patient with antibiotics, however it did not recover. Therefore, a revision was performed on (b)(6) 2017. The revision was completed and all devices were removed. It is reported there was a surgical delay over thirty minutes during the revision surgery. The surgeon confirmed osteolysis or bone resorption around screw holes while removing the screws. Additional information was requested but has not been received at this time.
 
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Brand NameLACTOSORB TRAUMA PLATING SYSTEM
Type of Device2.0 LACTOSORB L- PLATE LEFT REGULAR
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer (Section G)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer Contact
michelle cole
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key6913398
MDR Text Key248116983
Report Number0001032347-2017-00748
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK955729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number915-2102
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/04/2017 Patient Sequence Number: 1
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