MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MINI PLATE, 4-HOLES, STRAIGHT (1/P); IMPLANT

Model Number	55-10504
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.The product was discarded by the facility at their location.
Event or Problem Description
It was reported by a company representative that a patient developed a possible post-surgical infection after initial implantation with an implant.The original procedure was reported as completed successfully without a delay, but a revision surgery occurred to remove the screws and a broken plate.
Event or Problem Description
It was reported by a company representative that a patient developed a possible post-surgical infection after initial implantation with an implant.The original procedure was reported as completed successfully without a delay, but a revision surgery occurred to remove the screws and a broken plate.
Additional Manufacturer Narrative
The reported event of a broken plate could be confirmed, because the plate (2 fragments) was returned (s.Fig.1) along with another intact plate and 7 intact screws.The aligned ct scans (s.Fig.2) in company with the complaint information were forwarded to the stryker health care professional.He stated that according to the related instruction for use, the 2.0 mini plates are not indicated for fixation of mandibular angle fractures, and therefore, the surgeon used this plate off-label.Documented by phd (b)(6), clinical expert, for stryker leibinger on (b)(6) 2020.Because of the aligned ct scans that were evaluated by stryker health care professional no further physical inspection needs be performed and no material / expanded investigation activities were deemed necessary.It has also been reported that the patient had an infection.However, in a follow-up, the sales rep has mentioned that the patient has poor hygiene.Surgeon also confirms that the infection was related to the procedure and not the device.No lot number was provided and a review of the specific manufacturing batch record and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) cannot be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lot.Based on evaluation there is no indication for an incorrectly working product or 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.

• Brand Name: MINI PLATE, 4-HOLES, STRAIGHT (1/P)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 9910264
• Report Number: 0008010177-2020-00019
• Device Sequence Number: 3355483
• Product Code: JEY
• UDI-Device Identifier: 04546540356208
• UDI-Public: 04546540356208
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K014263
• 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): 04/13/2021

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: 55-10504
• Device Catalogue Number: 55-10504
• Device Lot Number: UNKNOWN LOT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/13/2021
• 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