MAUDE Adverse Event Report: SYNTHES USA 2.0MM TI EMERGENCY SCREW W/FLUTED TIP 4MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 400.784

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Additional product code: jey.(b)(4).Lot number provided, a2l2d030105, cannot be confirmed as a valid lot number.Device remains implanted, will not be returned for evaluation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

A patient reported that he underwent surgery on (b)(6) 2005 for a genioglossus advancement procedure for sleep apnea and believes that he may have developed an allergic reaction to the still implanted devices.The patient stated that he was implanted with three known synthes screws along with a plate and cable, manufacturer unknown.He reported that he first experienced a reaction to a nickel belt buckle within the first few years of his surgery that resolved once he stopped wearing the nickel buckle.He then reported a rash at the site of his wedding ring which he can no longer wear.Within the past year, he has experienced a rash to his fingers that holds his fork as well as a rash to his wrist where he wore a watch and (b)(6).Finally, his wife placed magnets around his neck for cervical pain and he developed a severe reaction to it described as ¿almost burn like¿.The patient stated that the rash resolved once he removed the magnets and that he did not see a physician or treat it with anything.Per the patient, his biggest complaint at the current time is constantly being tired.The patient stated that he has an upcoming appointment on (b)(6) 2017 to see an allergist.Concomitant devices: plate (quantity 1); cable (quantity 1).This report is for one 2.0 mm ti emergency screw w/fluted tip 4 mm.This is report 3 of 3 for (b)(4).

• Brand Name: 2.0MM TI EMERGENCY SCREW W/FLUTED TIP 4MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6421693
• MDR Text Key: 70489805
• Report Number: 2520274-2017-10968
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/24/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 400.784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN CABLE; UNKNOWN PLATE
• Patient Outcome(s): Required Intervention