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

Catalog Number	78-30020
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by a company representative that post-operatively a ct scan was performed that determined an implant plate had fractured after the initial surgery.A revision procedure is planned to remove the broken plate and implant a new one.
Additional Manufacturer Narrative
The device was returned for evaluation, thus the reported event could be confirmed.Further information (e.G.Initial implantation date, postoperative images after initial implantation, surgeon¿s reports) was requested regarding the reported event.However, no further information was received.It was mentioned in the event description that a month after initial plate implantation the patient had developed an infection.Thus, the bone was removed.The removal of bone graft for this type of mandible reconstruction (primary reconstruction) is considered as an off-label use.In the related brochure (cmf-br-97-rev.None_14002), catalog 78-30020 is illustrated to be used for primary mandible reconstruction.The design proposal (request id 1806081005, rev.1, 2018-06-11) specific to this device shows that the plate has a profile height of 2.0 mm and is intended to be used for mandible reconstruction with bone grafts.The evaluation has shown that there are no indications for any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.
Event or Problem Description
It was reported by a company representative that post-operatively a ct scan was performed that determined an implant plate had fractured after the initial surgery.A revision procedure is planned to remove the broken plate and implant a new one.

• Brand Name: CUSTOMIZED MAND. RECON PLATE20, HEMI
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8432218
• Report Number: 0008010177-2019-00007
• Device Sequence Number: 19277754
• Product Code: JEY
• UDI-Device Identifier: 07613252599647
• UDI-Public: 07613252599647
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 78-30020
• Device Lot Number: 1806081005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1