MAUDE Adverse Event Report: SYNTHES BRANDYWINE 7.0MM TI SIDE-OPENING SCREW; APPLIANCE,FIXATION,SPINAL INTERLAMINAL

Catalog Number 498.750

Device Problem Bent (1059)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient initials are (b)(6).Patient weight unknown/not provided by reporter.Unknown when the patient developed adjacent level stenosis / disc disease at the l1-l2 level.Additional codes: mnh, mni.Device is not expected to be returned for manufacturer review/investigation.Device history records was conducted.The report indicates that the: mfg.Date, 07/07/14, part # 498.750 lot # 7733708, review of the device history records showed that were no issues during the manufacture of the product that would contribute to this complaint condition.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 a patient had an l2-ilium posterior lumbar fusion utilizing synthes uss instrumentation on (b)(6) 2014.At an unknown time, the patient developed adjacent level stenosis / disc disease at the l1-l2 level.There was no apparent product problem with the uss hardware from the (b)(6) 2014 surgery, and the patient had a solid fusion.On (b)(6) 2016, a revision procedure was performed and new uss screws were placed bilaterally from t10-l1.The l2 uss screws, nuts and collars were then removed.When removing the two l2 uss screws, it was noticed that the screws had become bent at some unknown time, (image attached), although this had no apparent effect, as the patient was fused.Extension connectors were placed on the existing rods, and new rods were connected onto the extension connector.No screws were replaced at the l2 level in order to ensure there was room for the extension connector.The surgeon then connected all the new screws to the new rods and tightened everything dow.The procedure was successfully completed.Eight devices will be assessed on this complaint (2 screws, 2 collars, 2 nuts, and 2 rods) this report is 2 of 7 for (b)(4).

• Brand Name: 7.0MM TI SIDE-OPENING SCREW
• Type of Device: APPLIANCE,FIXATION,SPINAL INTERLAMINAL
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5420305
• MDR Text Key: 37837664
• Report Number: 2530088-2016-10025
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK141897
• 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
• Report Date: 01/22/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.750
• Device Lot Number: 7733708
• Other Device ID Number: (01)10705034791623 (10)7733708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR