MAUDE Adverse Event Report: SYNTHES BRANDYWINE 7.0MM TI SIDE-OPENING SCREW 55MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 498.755

Device Problem Bent (1059)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Additional device product codes are mnh and mni.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested 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 revision surgery was performed on (b)(6) 2016 due to patient pain, screw loosening and spacer migration.One screw was also reported to have been bent as well.The patient initially underwent a l5-s1 posterior lumbar fusion on (b)(6) 2016 during which time synthes universal spine system devices and non-synthes musculoskeletal transplant foundation (mtf) t-plif (transforaminal posterior lumbar interbody fusion ) 11-mm spacer for the interbody fusion were implanted.The patient had a spondylolisthesis that the surgeon corrected on during the (b)(6) 2016 surgery.On an unknown date the patient complained of pain.The surgeon found that the mtf t-plif spacer had migrated posteriorly into the spinal canal sometime after the initial implant procedure based on imaging performed on an unknown date.During the (b)(6) 2016 revision surgery, the surgeon removed four uss nuts, four uss collars, and the mtf t-plif implant.The l5 screws were found to be loose and had pulled out slightly, and thus the t-plif migrated posteriorly due to the loss of compression.The left s1 screw appeared to be bent when it was removed from the patient.The surgeon replaced the 7mm screws with 8mm, and replaced the 11mm implant with a 13mm t-plif implant.He then reused the same rods and connected them to the screws with new nuts and collars.The surgeon elected not to reduce the spondylolisthesis on this revision due to the patient's bone quality.The surgery was successfully completed.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Manufacture date: december 18, 2015.Review of the device history records showed that 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: 7.0MM TI SIDE-OPENING SCREW 55MM
• 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: 5441793
• MDR Text Key: 38367180
• Report Number: 2530088-2016-10052
• 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,Followup
• Report Date: 01/26/2016

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: 498.755
• Device Lot Number: 9967213
• Other Device ID Number: (01)10705034791630(10)9967213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: QTY 4, 498.010, 6.0MM TI COLLAR
• Patient Outcome(s): Required Intervention
• Patient Weight: 130