MAUDE Adverse Event Report: SYNTHES USA TI MATRIX TOP LOADING POLYAXIAL HEAD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.632.001S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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

Device report from synthes europe reports an event in (b)(6) as follow: it was reported that on (b)(6) 2016, the patient underwent initial spinal fusion surgery due to lumbar spinal canal stenosis and degenerated scoliosis.At that time, six (6) bone-screws and six (6) screw-heads were used to fix at l3-l5.After the surgery on unknown date, patient suffered from the adjacent intervertebral disc disorder.The revision surgery was performed on (b)(6) 2016, and the initial implanted screw-heads were removed, and decompression was performed.Then, additional screws were implanted at l2-s1.The surgeon commented that the cause of the disc order was not related to the product defects.The disc order was easy to occur naturally due to post spinal fusion.The revision surgery was completed successfully, and the patient's condition was reported as stable.During the revision surgery, an instrument problem occurred.Events occurred during revision procedure are captured under (b)(4).This report is for one (1) ti matrix top loading polyaxial head.This is report 8 of 12 for (b)(4).

Manufacturer Narrative

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

The surgeon commented the cause of the adjacent intervertebral disc disorder was not related to the products defects.Patient outcome reported as under observation.

• Brand Name: TI MATRIX TOP LOADING POLYAXIAL HEAD
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6142277
• MDR Text Key: 61350763
• Report Number: 2520274-2016-15562
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 04.632.001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR