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

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient weight not available for reporting.510k: this report is for an unknown spinal implant.Part and lot numbers are unknown; udi number is unknown.It is not verified that device is a synthes manufactured device.Date of explant reported as sometime in (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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.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

It was reported that a patient has expressed that her three-level cervical spine fusion at c5, c6, c7, that took place on (b)(6) 2016 was unsuccessful, the implants were infected with (b)(6).The patient underwent a revision procedure this past month on an unknown date.The amount of devices that were removed is unknown and if the patient was revised to other hardware.It is also unknown who manufactured the implants.It was only reported that it could be depuy synthes or depuy spine.Surgical delay or patient harm during the initial and revision procedures are also unknown.This report is for one (1) unknown spine implant this is report 1 of 1 for (b)(4).

• Type of Device: IMPLANT, FIXATION DEVICE, SPINAL
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6602383
• MDR Text Key: 76311923
• Report Number: 2520274-2017-11751
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2017

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2017
• Initial Date FDA Received: 05/31/2017
• 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