MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG CUSTOMIZED MAND. RECON PLATE20, HEMI; IMPLANT

Model Number 78-30020

Device Problems Loss of or Failure to Bond (1068); Failure to Osseointegrate (1863)

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported that during a scan of the patient, the surgeon located a non union of bone graft.The surgeon completed a reconstruction surgery to remove the plate.The surgical procedure was completed successfully and no other information is known at this time.

Event Description

It was reported that during a scan of the patient, the surgeon located a non union of bone graft.The surgeon completed a reconstruction surgery to remove the plate.The surgical procedure was completed successfully and no other information is known at this time.

Manufacturer Narrative

The device was not returned nor any documents (e.G.Scans of the reported non-union) have been provided for evaluation.Thus, the reported event could not be confirmed.In the complaint analysis performed by customized mandible recon plate design team, it was stated that ¿the fit of the plate was perfect.¿ in a follow-up email, the sales rep could not provide the date when the reported non-union has been discovered by the surgeon nor is he aware whether the patient is compliant to postoperative care instructions.A review of the design proposal has shown that the patient presented in this case had undergone mandible surgery prior to the described fibula free flap reconstruction with the reported device (performed on 2018-oct-30) in the event description.The designed cmrp has a total of 9 holes for the revision (3 on each side of the parasymphyseal region) (see fig.1).As described in the event description, the surgeon has used only 6 screws (50-20510) for the procedure.These screws are appropriate to be used for the reported plate.However, the use of only 6 screws (presumably 2 screws on each side of the parasymphysis) is considered as off-label use, as the related instructions for use (ifu#: 90-02023 rev.2) recommends that a minimum of 3 locking screws should be used on each side of the resection.As a result of the reported non-union, it is stated in the event description that ¿plate was removed, bone was debrided and plated with rigid internal fixation.Procedure went well and or is doing ok.¿ conclusively, no indications for an incorrectly working product or any systematic design, material or manufacturing related issue were found.Therefore, no corrective and / or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.H3 other text : device is not available for evaluation.

• Brand Name: CUSTOMIZED MAND. RECON PLATE20, HEMI
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 9565467
• MDR Text Key: 187051112
• Report Number: 0008010177-2020-00005
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07613252599647
• UDI-Public: 07613252599647
• Combination Product (y/n): N
• PMA/PMN Number: K132519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 78-30020
• Device Catalogue Number: 78-30020
• Device Lot Number: 1810171011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other