MAUDE Adverse Event Report: SYNTHES USA; NO CODE AVAILABLE

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

Patient Problems Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of post-operative symptom onset is unknown.This report is for one (1) unknown patient specific implant (psi).Without a valid part and lot number, the udi is not available.The original implant procedure was performed on an unknown date.The device has not been explanted.The complainant part is not expected to be returned for manufacturer review/investigation.Patient: to report the potential allergic reaction experienced by the patient.Unknown, as specific part and lot numbers for the complainant psi are unknown.A potential 510k number for the device is k033868.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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 may be experiencing an allergic reaction to a patient specific implant (psi) composed of polyetheretherketone (peek) material.An update from the reporter was received on (b)(6) 2016 indicating that the opinion is that the allergic reaction is not due to the synthes implant.No additional information is available.This report is for one (1) unknown psi device.This report is 1 of 1 for (b)(4).

• Type of Device: NO CODE AVAILABLE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5486102
• MDR Text Key: 39935273
• Report Number: 2520274-2016-11529
• Device Sequence Number: 1
• Product Code: GXN
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2016
• 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