MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI PARALLEL CONNECTOR 5.0MM/6.0MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Catalog Number 498.162

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes used kwp, mni, mnh and nkb.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review has been requested.(b)(4).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 the patient underwent surgeries for adjusting veptr size on (b)(6) 2013 and (b)(6) 2014 respectively.On (b)(6) 2014, it was noticed that patient had mrsa infection and insufficient fusion on the wounded area.A cultivation test was performed and the result was (b)(6).On (b)(6) 2014, patient underwent removal procedure and only the veptr, stabilized between the left 5th lib and the ileum was removed.Patient outcome was reported as well.Reportedly, the veptr treatment has continued.Patient¿s past and future patient histories are captured in linked complaints (b)(4) respectively.This report is for one (1) ti parallel connector 5.0mm/6.0mm.This is report 1 of 9 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 498.162, lot# 7582949.Manufacturing location: (b)(6), manufacturing date: apr 30, 2014.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 history records review was completed for the parent lot number (7582949) and all raw material lots used to manufacture the device.Component (b)(4) ¿ raw material of 498.162, lot number 5374016, component (b)(4) ¿ set crew, m5, lot number 7428157, and component (b)(4) ¿ raw material of set crew, m5, lot number 4449451.Review of the device history records showed that there were no issues during the manufacture 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 PARALLEL CONNECTOR 5.0MM/6.0MM
• Type of Device: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6602550
• MDR Text Key: 76371476
• Report Number: 2530088-2017-10130
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07611819717206
• UDI-Public: (01)07611819717206(10)7582949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

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: Physician
• Device Catalogue Number: 498.162
• Device Lot Number: 7582949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Weight: 17