MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LE FORT I PLATE, 4MM ADVANCEMENT, RIGHT, 11 HOLE, MIDFACE; IMPLANT

Model Number	55-12704
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Devices not received from facility.
Event or Problem Description
It was reported that the surgeon removed four plates, and all of them were broken, all in the same area.The original procedure, a lefort orthognathic osteotomy, was done in (b)(6) of 2019.The patient¿s bone never properly healed and she has underlying health issues (osteoarthritis).A revision surgery is planned.
Additional Manufacturer Narrative
Corrected data: return was not anticipated initially, but was actually received.This has been indicated in this supplemental report.The investigation results show that the postoperative plate fractures occurred through holes, 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 deterioration of the anodization layer and the changes of the surface¿s structure in the area of the breakage.The fracture surfaces were partially leveled due to friction with the counterpart or another hard object.The undestroyed fracture surfaces (rest) show the appearance of a forced rupture.The fractographic investigations with sem show a structure of a ductile forced rupture with secondary cracks and in addition, swinging lines of a fatigue breakage are visible.To obtain more details about the complained event, the sales rep was contacted, and several answers received.The stryker cmf¿s health care professional was contacted in order to assess the provided information ¿(¿) breakage of the plates was due to the nonhealing of the bone which in turn was probably related to degenerative bone disease.(¿)¿.In sum, all performed investigations indicate that the plate broke due to a forced rupture in combination with a fatigue breakage which was probably related to the degenerative bone disease of the patient.Based on the investigation and the corresponding investigation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.
Event or Problem Description
It was reported that the surgeon removed four plates, and all of them were broken, all in the same area.The original procedure, a lefort orthognathic osteotomy, was done in (b)(6) 2019.The patient¿s bone never properly healed and she has underlying health issues (osteoarthritis).A revision surgery is planned.

• Brand Name: LE FORT I PLATE, 4MM ADVANCEMENT, RIGHT, 11 HOLE, MIDFACE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10352189
• Report Number: 0008010177-2020-00038
• Device Sequence Number: 14243658
• Product Code: JEY
• UDI-Device Identifier: 04546540366412
• UDI-Public: 04546540366412
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022185
• 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): 12/04/2020

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 Model Number: 55-12704
• Device Catalogue Number: 55-12704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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