MAUDE Adverse Event Report: SYNTHES MEZZOVICO SYNFIX® EVOLUTION FINE TIP SCREW/25MM - STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Catalog Number 04.835.125.02S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device product code is ovd.Code xxx was utilized because system limitations would not allow for population of ovd.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: aug 19, 2016.Expiration date: aug 1, 2026.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformance reports (ncrs) were generated during the production of the subject device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reported an event in (b)(6) as follows: it was reported that one (1) synfix evolution screw at level s1 had backed out of the locking plate postoperatively.The patient initially underwent an anterior lumbar interbody fusion (alif) on (b)(6), 2016 at levels l5 ¿ s1.X-rays taken immediately postoperatively appear to show the screw in the force plate.The screw back out was discovered during a routine post-operative follow-up x-ray of the patient on (b)(6) 2017.The surgeon stated that the patient is ok at the moment as the patient is asymptomatic.There is no plan to revise the patient at this time.Concomitant medical products: 3x 04.835.125.02s lot.L072234; 1x 08.815.365s lot.9962607.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device has not been reported as explanted.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: SYNFIX® EVOLUTION FINE TIP SCREW/25MM - STERILE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6558335
• MDR Text Key: 75016399
• Report Number: 1000562954-2017-10057
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.835.125.02S
• Device Lot Number: L072234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 08.815.365S, SYNFIX EVOL SPAC 17MM HGT, QTY. 1