MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MINI PLATE, 6-HOLES (1/P); IMPLANT

Model Number	55-10506
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
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 by the health professional that the patient was implanted with a universal mandible mini plate 1.0mm.It was noticed post-operative, the plate was confirmed to be broken and there was a revision surgery to remove the plate.
Additional Manufacturer Narrative
Reported event of a broken plate could be confirmed, because a fragment of the plate (incl.2 and a half holes) was returned.Because of the x-rays provided that were evaluated by stryker health care professional no further physical inspection needs be performed and no material / expanded investigation activities were deemed necessary.The x-rays 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 fractures, and therefore, the surgeon used this plate off-label.The relevant manufacturing and inspection documents related to the reported device with catalog # 55-10506 have been reviewed.The review showed that the products were manufactured in accordance to specification.The related lot # 1000309128 indicates 158 devices were final released on 2018-jun-21 and accepted into final stock with no reported discrepancies.Based on 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 or Problem Description
It was reported by the health professional that the patient was implanted with a universal mandible mini plate 1.0mm.It was noticed post-operative, the plate was confirmed to be broken and there was a revision surgery to remove the plate.

• Brand Name: MINI PLATE, 6-HOLES (1/P)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 9764756
• Report Number: 0008010177-2020-00011
• Device Sequence Number: 16321970
• Product Code: JEY
• UDI-Device Identifier: 04546540356222
• UDI-Public: 04546540356222
• Combination Product (Y/N): N
• PMA/510(K) Number: K014263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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: No Information
• Device Model Number: 55-10506
• Device Catalogue Number: 55-10506
• Device Lot Number: 1000309128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/09/2020
• Supplement Date Received by Manufacturer: 02/09/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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: Other