MAUDE Adverse Event Report: SYNTHES GRENCHEN 4.0MM TI LOCKING SCREW-FINE TIP 25MM FOR SYNFIX-LR; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Catalog Number 04.802.212

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of postoperative screw back out is unknown.Device product code ¿xxx¿ used as the code applicable to ¿intervertebral fusion device with integrated fixation, lumbar¿ was not available for selection.The actual device code is ¿ovd.¿ (b)(4).(therapy date): implanted in (b)(6) 2016, exact date is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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

It was reported that the synfix implant was implanted in (b)(6) 2016 for degenerated disc disease.Post-operative x-ray revealed that the synfix lr screw began to back out post operatively.Revision surgery was performed on (b)(6) 2017 to remove the screw.No new implants were implanted and screw was removed intact.There was no delay and surgery was completed successfully and patient was reported as stable.Concomitant devices reported: synfix-lr implant (quantity # 1).This report is for one (1) 4.0 mm ti locking screw-fine tip 25 mm for synfix-lr.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Complainant part is no longer expected to be returned for manufacturer review/investigation.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: 4.0MM TI LOCKING SCREW-FINE TIP 25MM FOR SYNFIX-LR
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer (Section G): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6575760
• MDR Text Key: 75459573
• Report Number: 3009450884-2017-10066
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.802.212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2017
• 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
• Patient Outcome(s): Required Intervention