MAUDE Adverse Event Report: SYNTHES (USA); IMPLANT, FIXATION DEVICE, SPINAL

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that during a presentation for the national spine meeting, one of the slides stated the following: ¿patient implanted with rod construct experienced a rod breakage post-operatively.Surgeon presenting noted that the patient returned to the operating room for revision surgery.¿ no additional information was provided.It is not known if the broken rod was a synthes device.This report is for one unknown spinal rod.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is unknown.This report is for one unknown spinal rod.Implant and explant dates are unknown.Without a lot number the device history records review could not be completed.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

Per surgeon, the patient was referred to him by another surgeon.The patient had revision surgery to stabilize the construct.No parts removed.Surgeon stated the patient is ill and will not tolerate a major surgery.Surgeon also stated the original surgeon does not routinely use depuy or synthes parts and he thinks it is highly unlikely such parts were used with the original surgery.

Manufacturer Narrative

Additional 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.

• Type of Device: IMPLANT, FIXATION DEVICE, 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: 4471523
• MDR Text Key: 5403539
• Report Number: 2520274-2015-10670
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention