MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW; SCREW, FIXATON, BONE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product - biomet lactosorb l-plate right- regular catalog #: 915-2101 lot #: ni, biomet lactosorb l-plate left - regular catalog #: 915-2102 lot #: ni.Concomitant medical product: therapy date - (b)(6) 2017.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, the revision has not yet occurred.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: 0001032347-2018-00016 and 0001032347-2018-00017.

Event Description

It was reported the patient had a le-fort 1 osteotomy procedure and developed a complication after 8 months.Osteolysis was observed at zygomaticoalveolar line.Therefore, a revision will be scheduled to remove products.Additional information was requested, however at this time the complication experienced by the patient is unknown.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00016-1 and 0001032347-2018-00017-1.

Event Description

It was reported the revision occurred, however the date is unknown.During the revision it was identified the products were absorbed into the patient's body; therefore no product is available for evaluation.

Event Description

The distributor provided additional information.Although it was reported that there was revision, there was no revision at the time.The maxillary sinusitis was observed in (b)(6) 2018 and the surgeon performed cleaning and curettage to the patient as the treatment, not revision.After that, the patient have recovered well but the revision was performed to remove the remaining products inside of the patient's body on (b)(6) 2018 because osteolysis was observed again; see associate reports 0001032347-2018-00492, 0001032347-2018-00493, and 0001032347-2018-00494.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Date of event: the event occurred sometime in (b)(6) 2018.(b)(4).Pma/510(k) number: updated from k002083 to k971870.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00016-3 and 0001032347-2018-00017-3.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.There was a revision, therefore the complaint is considered confirmed.No further information was provided to explain the meaning of "complication" in the complaint report, and visual inspection and functional testing could not be performed due to the parts not being returned.However, osteolysis, or bone resorption was reported to have been observed at the zygomaticoalveolar line.Also, the patient initially had a le-fort 1 osteotomy performed on (b)(6) 2017, which is done to correct facial deformities.This information indicates that the most likely underlying cause of the complaint is patient condition.The instructions for use (ifu) has the following information for which the product should not be used under the section titled contraindications: patient conditions including, blood supply limitations, insufficient quantity or quality of bone stock or latent infection.Device history record (dhr) review was unable to be performed as the lot numbers of the devices involved in the event are unknown.Investigation results concluded that the reported event was due to patient condition.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: 0001032347-2018-00016-2 and 0001032347-2018-00017-2.

• Brand Name: 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW
• Type of Device: SCREW, FIXATON, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7178270
• MDR Text Key: 96839511
• Report Number: 0001032347-2018-00018
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK971870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 915-2301
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01) 0 0841036 05502 8
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention