MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: TRAUMA; SCREW, FIXATION, BONE

Device Problem Off-Label Use (1494)

Patient Problem Loss of Vision (2139)

Event Date 10/29/2021

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the orbital floor surgery with implanted synpor.Then the surgeon observed the patient for seven(7) hours post-op and performed the visual function examination every 1 hour.Six (6) hours later, the patient vomited and then showed blindness after vomiting.This report is for one (1) unk - screws: trauma.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

This report is for an unk - screws: trauma/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13054862
• MDR Text Key: 285649045
• Report Number: 8030965-2021-10369
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: 0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SYNPOR SMOOTH/TIT ORBIT FLOOR MESH PL RA