MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG L-PLATE, 100 DEGREE, 5MM BAR, RIGHT, MALLEABLE, 5 HOLE, MIDFACE; IMPLANT

Model Number	55-04763
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that the patient¿s bone did not heal properly.She does have underlying health issues (osteoarthritis).The surgeon removed the plates, and all four plates were broken.The original procedure, a lefort orthognathic osteotomy, was done in (b)(6) of 2019.The surgeon is doing revision surgery.Three additional mdrs will be filed to represent the other catalog numbers associated with this event.
Event or Problem Description
It was reported that the patient¿s bone did not heal properly.She does have underlying health issues (osteoarthritis).The surgeon removed the plates, and all four plates were broken.The original procedure, a lefort orthognathic osteotomy, was done in (b)(6) 2019.The surgeon is doing revision surgery.Three additional mdrs will be filed to represent the other catalog numbers associated with this event.
Additional Manufacturer Narrative
The investigation results show that the postoperative plate fracture occurred through a 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 1.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 destroyed / leveled due to friction with the counterpart or another hard object.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.

• Brand Name: L-PLATE, 100 DEGREE, 5MM BAR, RIGHT, MALLEABLE, 5 HOLE, MIDFACE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10427309
• Report Number: 0008010177-2020-00046
• Device Sequence Number: 3669057
• Product Code: JEY
• UDI-Device Identifier: 04546540365545
• UDI-Public: 04546540365545
• 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): 12/21/2020

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: 55-04763
• Device Catalogue Number: 55-04763
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 12/21/2020
• 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