MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.7X3MM, MIDFACE, (5/PACKAGE); IMPLANT

Catalog Number	50-17903
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/05/2019
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 a surgeon that after a mandibular distraction surgery was completed it was determined post-operatively the posterior part of the left implant had "drifted off", which caused a revision surgery to be scheduled.During that revision surgery it was found that there was no plate or screw fracture, and the surgeon reported it was not believed to be a product problem.
Event or Problem Description
It was reported by a surgeon that after a mandibular distraction surgery was completed it was determined post-operatively the posterior part of the left implant had "drifted off", which caused a revision surgery to be scheduled.During that revision surgery it was found that there was no plate or screw fracture, and the surgeon reported it was not believed to be a product problem.
Additional Manufacturer Narrative
Corrected data: although the original reported device in this complaint was the pmd 2 device that was returned, during the product complaint investigation it was determined that the actual reported device should have been the screws involved in the surgical procedure.That has been updated in this supplemental report.Additional manufacturer narrative (product complaint investigation conclusion) - a confirmation of the reported event that ¿the plate drifted off¿, which is related to screw loosening, was not applicable since the screws were not returned for investigation.After the initially reported event the sales rep provided the following update and additional information: ¿(¿) sales rep called after explantation was performed last night.Just the posterior part of the left implant had been affected; however, there was no plate/screw fracture.The surgeon does not believe this is a product problem.He shared that prior to this event, the patient had been vomiting.The nurse had inverted the patient to assist, and in doing so held on to the patient's chin.During the explantation, another bone plate was implanted since the desired distraction amount had been achieved.¿ the information provided indicates the loosening of the screws under this complaint is not related to a product problem but related to the patient vomiting and, especially, the forces occurred within the assistance of the nurse.Based on statistical evaluation there are no indications for any systematic design, material, or manufacturing related issue.Therefore, no preventive and/or corrective actions are deemed necessary at this time.The complaint is added to the complaint trend.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.7X3MM, MIDFACE, (5/PACKAGE)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8434437
• Report Number: 0008010177-2019-00011
• Device Sequence Number: 2446341
• Product Code: JEY
• UDI-Device Identifier: 07613327291377
• UDI-Public: 07613327291377
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K181504
• 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): 06/13/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 50-17903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1