MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI COLLAR FOR 6MM DUAL-OPENINGIMPLANTS

Catalog Number 499.292

Device Problems Bent (1059); Break (1069)

Patient Problem No Code Available (3191)

Event Date 06/04/2013

Event Type  Injury  

Event Description

Patient was implanted with synthes uss for l2-l3 posterior lumbar fusion in 2010.Patient developed adjacent level disease caudal to the solid l2-l3 lumbar fusion.Patient was returned to o.R.On (b)(6) 2013 for removal of all hardware.Patient was revised to uss dual opening from l2-ilium.Surgeon encountered issues with connecting the nut and collar onto the left iliac screw when the top threads on the screw that connect with the nut stripped.The surgeon then recannulated the ilium and replaced the left iliac screw with a 7 x 60mm screw, as well as the collar and nut, but encountered the same issue with the threads stripping.The surgeon then replaced the second stripped screw with a larger diameter 8 x 60mm screw, as well as the collar and nut, but again, the screw stripped when trying to engage the nut.The surgeon replaced the third stripped screw with another, as well as the collar and nut, and was finally able to get the nut to successfully thread onto the screw.It is reported one hook and screw holder was found to be bent during the procedure.It was reported, due to device malfunction it caused a delay greater than 30 minutes and that the procedure was completed with no further problem, no harm to patient.This is report 24 of 25 for complaint (b)(4).

Manufacturer Narrative

Device used for treatment not diagnosis.Additional product codes: kwq, mnh, mni.Date of original implant reported only as 2010.The device history records were reviewed and no complaint related issues were found.Manufacturing evaluation reports the device was received with deep scratches and nicks on the face and side of the collar, where the anodize finish has been removed.These observations are not manufacture related.All relevant features conform to product specifications, this complaint is deemed invalid from a manufacturing perspective.Product development event evaluation details the screws, collars and nuts are found in the dual-opening uss system (technique guide).The assembly of the screw, collar, nut and rod are used for spinal deformity correction.As reported, having the difficulty of engaging the nuts on the uss screws while seating the rods with the collars is possibly indicative of the rod not being fully seated in the screw.If the nut is not placed proper aligned with the mating pedicle screw threads, cross-threading can occur damaging the screw and nut.The part drawings were reviewed and the materials and specifications are adequate for the devices intended use.The set contains instruments to help persuade/bend the rods to accommodate a wide variety of surgical instances and patient anatomy.Since there is not enough information concerning the placement of the rod during the procedure, this complaint is deemed indeterminate from a design perspective.Placeholder.

• Brand Name: TI COLLAR FOR 6MM DUAL-OPENINGIMPLANTS
• 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: a martin ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3627608
• MDR Text Key: 22135975
• Report Number: 2530088-2014-00036
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2013

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: 499.292
• Device Lot Number: 7376031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2013
• Initial Date FDA Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR