MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB TRAUMA PLATING SYSTEM; PLATE, FIXATION, BONE

Model Number N/A

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

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: (b)(6) 2018.Implant date: (b)(6) 2018.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted in the patient and is partly resorbed.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the plate was implanted in (b)(6) 2018.It has taken a long time for the patient to heal and recover.In (b)(6) 2018, the surgeon "treated and washed the diseased part," instead of removing the plate as planned.In (b)(6) 2018, the patient recovered and was discharged.Attempts have been made and no further information has been provided.No additional patient consequences were 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.Reported event was unable to be confirmed due to limited information received from the customer.The unknown lactosorb plate remains implanted and was therefore not returned for investigation.The plate was implanted on the patient's cranium in march 2018.An infection occurred approximately four months later, but because the lactosorb was already partially resorbed, it was not removed and the area was cleaned.Because the part was not returned and no photos were provided, visual evaluation and functional testing could not be conducted.The device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: LACTOSORB TRAUMA PLATING SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8156167
• MDR Text Key: 130164070
• Report Number: 0001032347-2018-00853
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K971870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention