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

Catalog Number 498.103

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); 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).Patient age & weight not available for reporting.Unknown when pain, non-union or breakage occurred.Additional product code: mni.(b)(4).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 surgery on (b)(6) 2015 to treat a sacral u fracture and also a pelvis fracture.In this initial surgery the patient had a posterior spinal fusion and was instrumented with uss fracture at l5, skipped s1 due to fracture, and was instrumented in the ilium with synthes uss (bilateral construct).The patient also had a 7.3 x 155mm cannulated ss synthes ortho screw placed transsacral.The patient did not heal and at an unknown point in time the patient broke both rods just cranial to the iliac screws.The patient also broke the 7.3 x 155mm cannulated screw.In additional, pain, irritation and discomfort was reported.It is unknown where the location of the pain is.On (b)(6) 2016, the spine surgeon performed the revision.He removed all the hardware from the (b)(6) 2015 procedure, which included the two broken rods.The spine surgeon then reinstrumented the patient with depuy expedium 5.5mm rod system.He replaced both l5 screws, replaced both iliac screws, and then placed 2 more iliac screws alongside of the others.He placed new rods and successfully completed the procedure.After the spine surgeon had completed the spine part of the procedure, the ortho trauma surgeon came in and removed the two (2) broken pieces of the 7.3mm x 155mm cannulated screw and placed a new cannulated screw and successfully completed the procedure.There was no report of any surgical delay and patient status is unknown.This complaint involves 3 parts.This report is 1 of 3 for (b)(4).

• Brand Name: 6.0MM TI HARD ROD 75MM
• Type of Device: ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION
• 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: 5636886
• MDR Text Key: 44612135
• Report Number: 2520274-2016-12575
• 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: 04/19/2016

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: 498.103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/06/2016
• 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