MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES, WITH TEMPLATE; IMPLANT

Catalog Number	55-15911
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	06/25/2018
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 that right mandibular osteonecrosis occurred within the patient, as well as a mandibular reconstruction plate fracture.A revision surgery was performed to remove the fractured plate and implant another mandibular reconstruction plate.
Additional Manufacturer Narrative
Additional details regarding the reported event have been requested such as the date of initial implantation, postoperative x-rays during initial surgery as well as the time the breakage has occurred.The reported plate was implanted on (b)(6) 2015.A postoperative image of the plate after implantation (dated (b)(6) 2015, fig.2) has been received.The plate is still intact.However, the x-ray illustrates the plate has been implanted without a bone graft.The use of primary reconstruction plates for secondary reconstructions is considered as off-label use.Prior to explantation on (b)(6) 2018, an x-ray (dated (b)(6) 2018, fig.3) has been provided that shows the broken plate.The event ¿breakage ¿ postoperative¿ could be confirmed.Further, this case has been presented to stryker¿s medical expert.He stated: ¿(¿) if the gold primary recon plate was in fact used, it was the wrong plate.Only a secondary recon plate (silver) should have been used.(¿)¿.In the related instructions for use (ifu 90-01939, rev.7, 2017-jul-24), it is stated that: ¿(¿) 2.Contraindications (¿) secondary reconstructions with universal primary recon plates (gold colored).(¿) primary reconstruction (gold color) plates are not intended for use in secondary reconstruction applications.Use of such may result in excessive plate loading and premature failure.(¿)¿ also, in the related brochure, leibinger universal 2 (9410-400-184, 2011), it is stated that primary recon plates (color-coded gold) are for the following indications: ¿(¿) 1.For the fixation of microvascular grafts only (e.G.Fibula, radius, scapula, iliac crest) in a single step reconstruction after resection of a tumor, osteomyelitis or osteonecrosis (¿)¿ based on the performed investigation, there is no product malfunction indicated nor any systematic design, material or manufacturing related issue.
Event or Problem Description
It was reported that right mandibular osteonecrosis occurred within the patient, as well as a mandibular reconstruction plate fracture.A revision surgery was performed to remove the fractured plate and implant another mandibular reconstruction plate.

• Brand Name: PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES, WITH TEMPLATE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7847855
• Report Number: 0008010177-2018-00086
• Device Sequence Number: 11097190
• Product Code: JEY
• UDI-Device Identifier: 04546540356376
• UDI-Public: 04546540356376
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K014263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 55-15911
• Device Lot Number: TBD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR