MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PRIMARY HEMI MANDIBULAR RECONSTRUCTION PLATE, LEFT, 5+17-HOLES, WITH TEMPLATE; IMPLANT

Model Number 55-15922

Device Problems Break (1069); Fracture (1260); Material Protrusion/Extrusion (2979)

Patient Problems Failure of Implant (1924); Pain (1994); No Information (3190)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device is implanted in patient.

Event Description

It was reported by a health care professional that a patient's x-ray revealed a broken implant plate.There is no information available on how the plate broke or whether revision surgery is planned.

Manufacturer Narrative

Corrected data: the actual device was returned for evaluation when initially it was indicated that it would not be returned.Investigation results: the investigation results show that the postoperative plate fracture occurred through a fixing hole, so the reported event could be confirmed.The (measurable) dimensions of the returned plate are in accordance with the specifications.The chemical composition conforms to the specification of ti grade 2.The macroscopic appearance points to exceeding the material strength.That is confirmed by the deteriora-tion of the anodization layer and the changes of the surface¿s structure in the area of the breakage.The fracture surface was partially leveled due to friction with the counterpart.The non-destroyed fracture surface (rest) shows the appearance of a forced rupture.The fractographic investigation with sem shows a structure of a ductile forced rupture with secondary cracks and in addition, swinging lines of a fatigue breakage are visible.In comparison to the straight reference line the plate was bent through a fixing hole.All relevant quality documents (manufacturing and inspection documents) have been reviewed.The device history record for article# 55-15922 and lot/batch code# 1000288707 indicates 26 devices were manufactured and accepted into final stock on 2018-jan-23.No issues could be found in the manufacturing or inspection documents.To obtain more details about the complained event, the sales rep was contacted.On the provided x-ray, the affected fixing hole shows no inserted screw and is placed in the area between the new inserted fibula graft and the remaining part of the ramus (s.Fig.21).The provided complaint information (e.G.X-ray) was forwarded to the stryker health care professional, who stated the following: ¿(¿) the fibula graft is not a ¿micro vascular¿ bone graft, and there is a large gap between the fibula graft and the ramus.This gap does not meet the criteria for primary reconstruction and therefore a secondary recon plate (stronger) should have been used.(¿)¿.The plate broke postoperatively because of an overload supported by the large gap, which indicates an off label use.Due to the breakage of the plate, each fracture part has sharp edges that may cut through the skin.Therefore, extrusion can be a result of a postoperative plate breakage.According to stryker cmf¿s senior specialist clinical affairs ¿ clinical research: ¿(¿) possible other factors leading to this issue include but are not limited to sharp plate edges resulting from modifications of the product by the surgeon, perioperative radiation of cancer patients and insufficient soft tissue coverage of the implant.The performed perioperative radiation in the current case may also have influenced the occurrence of extrusion.(¿)¿.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.

Event Description

It was reported by a health care professional that a patient's x-ray revealed a broken implant plate.There is no information available on how the plate broke or whether revision surgery is planned.

• Brand Name: PRIMARY HEMI MANDIBULAR RECONSTRUCTION PLATE, LEFT, 5+17-HOLES, WITH TEMPLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 8438185
• MDR Text Key: 139699014
• Report Number: 0008010177-2019-00013
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 04546540356406
• UDI-Public: 04546540356406
• Combination Product (y/n): N
• PMA/PMN Number: K014263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55-15922
• Device Catalogue Number: 55-15922
• Device Lot Number: 1000288707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0