MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNIII AXS SCREWS, SELF-DRILLING, 1.5X4MM, 5/P; IMPLANT

Catalog Number	56-15934
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/25/2018
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.Device discarded at the facility.
Event or Problem Description
It was reported that an orbital floor plate needed to be removed because the patient began experiencing double vision.
Event or Problem Description
It was reported that an orbital floor plate needed to be removed because the patient began experiencing double vision.
Additional Manufacturer Narrative
The reported event could not be confirmed, because the product was not returned for investigation and the information provided was not sufficient.No lot number was provided, thus a review of the specific manufacturing batch records 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.To obtain more details about the complained event, the sales rep was contacted.No pre-operative images could be provided that illustrate the implant position relatively to the eye.Also no information about the experience level of the involved surgeons with respect to orbital floor reconstructions was available.It was additionally unknown if swelling was involved in the initial surgery that might caused the orbital contents not to be in an accurate position during the initial procedure.Finally it was stated that the orbital floor plate was replaced by ¿a straight 0.85 medpor implant¿, because there was still a small defect the surgeon wanted to place the implant over.Finally the r&d expert for neuro screws was contacted to assess this complaint.He stated that the currently complained neuro screws are not intended to be used for midface-applications.Thus this application is considered as off-label use that might have contributed to a non ideal reconstruction of the orbital floor and the resulting complained double vision of the patient.Based on the investigation, the corresponding statistical evaluation as well as the assessment of the stryker r&d expert for neuro screws there is no indication for a not correctly working product or any systematic design, material or manufacturing related issue.Therefore no further corrective and / or preventive actions are deemed necessary at that time.The complaint is added to the complaint trend.

• Brand Name: UNIII AXS SCREWS, SELF-DRILLING, 1.5X4MM, 5/P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7629640
• Report Number: 0008010177-2018-00054
• Device Sequence Number: 16598867
• Product Code: HBW
• UDI-Device Identifier: 37613327090735
• UDI-Public: 37613327090735
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151387
• 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): 07/19/2018

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: 56-15934
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/19/2018
• 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