MAUDE Adverse Event Report: SYNTHES USA 7.0MM TI DUAL-OPENING SCREW 50MM THRD LENGTH F/6.0MM RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 499.234

Device Problem Difficult To Position (1467)

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

Event Date 06/09/2014

Event Type  malfunction  

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 4 of 4 for (b)(4).

Manufacturer Narrative

Additional product codes: mni, mnh, kwp, kwq.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 no product was returned.Without a lot number the device history records review could not be completed.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: 7.0MM TI DUAL-OPENING SCREW 50MM THRD LENGTH F/6.0MM RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3917316
• MDR Text Key: 4585544
• Report Number: 2520274-2014-12387
• 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
• 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: 499.234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2014
• 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 Age: 51 YR
• Patient Weight: 66