MAUDE Adverse Event Report: SYNTHES USA 6.0MM TI HARD ROD 75MM; ORTHOSIS, PEDICLE SPINAL

Catalog Number 498.103

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

Patient Problems Irritation (1941); Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4) the patient did not heal, and had a non-union.Revision surgery was performed, and all the hardware was explanted.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient had a l3-l5 posterior spinal fusion on (b)(6) 2015 with synthes (b)(4).The patient had pain, irritation, and discomfort.According to the surgeon, the patient did not heal and has a nonunion.The patient went in for revision surgery on (b)(6) 2016.The surgeon explanted all the hardware from the (b)(6) 2015 surgery.There were no product issues with the hardware.There was no surgical time delay reported.The surgeon re-instrumented the patient with synthes (b)(4) from l3 to l5 and successfully completed the procedure.Patient status outcome is unknown.This complaint involves twenty devices.This report is 7 of 20 for (b)(4).

• Brand Name: 6.0MM TI HARD ROD 75MM
• Type of Device: ORTHOSIS, PEDICLE SPINAL
• 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: 5629162
• MDR Text Key: 44333200
• Report Number: 2520274-2016-12464
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992739
• 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
• Report Date: 04/18/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 498.103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/03/2016
• 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: 71 YR
• Patient Weight: 91