MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI COLLAR FOR 6MM DUAL-OPENING IMPLANTS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 499.292

Device Problem Difficult To Position (1467)

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

Event Date 06/09/2014

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: a manufacturing evaluation was completed: the device was received with a light scratch on the bottom of the collar.This is not manufacture related.All relevant features were verified and conformed to product specifications.Complaint is unconfirmed.A product development evaluation was completed: this ti collar (part 499.292, lot 7654716) was returned with the complaint of does not fit with other parts; however, upon examination of the part and review of the most recent version of the drawing to which this part was manufactured to in april 2014, it was seen that this part is intact, meets the dimensions of the drawing, and other than a minor surface scratch, shows no signs of damage, and mates properly with part 499.294.The design is adequate for its intended use and did not contribute to this complaint.This complaint is not confirmed.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 a deemed invalid from a design perspective.The complaint for this part is unconfirmed given the measurements and the visually acceptable condition that it was returned in.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 during a posterior l5 ¿ s1 fusion a nut cross threaded onto a screw in the right l5 position.The surgeon was performing the posterior l5 ¿ s1 fusion on the patient using titanium universal spine system dual opening during surgery on (b)(6) 2014.It was reported that the surgeon placed 8.0 x 50mm screws in s1 and 7.0 x 50mm screws in l5.After the screws were inserted, the surgeon performed the decompression.The surgeon then connected the rods (498.290 rod cut into 2 rods to be used on both sides).While connecting the rods, the surgeon could not get the nut to thread onto the screw located at the right l5.It was reported that the nut became cross threaded onto the screw.The surgeon then tried another nut and a collar on the right l5 screw.The new nut became cross threaded.The surgeon then tried another nut and it threaded onto the screw.The procedure was completed successfully.No patient harm was reported.There was a ten minute time delay.This is report 3 of 4 for (b)(4).

Manufacturer Narrative

Device cross threaded during insertion; device was not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: TI COLLAR FOR 6MM DUAL-OPENING IMPLANTS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 3915337
• MDR Text Key: 11995705
• Report Number: 2530088-2014-10177
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 499.292
• Device Lot Number: 7654716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 66