MAUDE Adverse Event Report: SYNTHES USA; PROSTHESIS INTERVERTEBRAL DISC

Catalog Number PRODISC-L

Device Problem Fitting Problem (2183)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown prodisc l inferior endplate/unknown lot number.Udi: unknown part number, unknown lot number, udi is unavailable.Not explanted.Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and the 510k#: unknown.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 the patient declare that his prosthesis is positioned at an angle such an open beak.It then does not the desired mobility.He must do x-rays in different positions to see if it's still moving.The patient always has constantly pain with periods in which the pain is very intense.In (b)(6) 2015, the crisis lasted about a month.In (b)(6) 2015, the crisis lasted 1 month 1/2 and the patient remained lying.He takes anti-inflammatory and analgesic.Status; resolved.The actual complication did not lead to a postoperative re-intervention.Comment from investigator: serious adverse event related to the prodisc l, inlay migration, onset date (b)(6) 2015.No motor or sensitive complications, no sexual or mechanic complications.This complaint involves 3 part.This report is 3 of 3 for (b)(4).

• Type of Device: PROSTHESIS INTERVERTEBRAL DISC
• 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: 5510726
• MDR Text Key: 40689677
• Report Number: 2520274-2016-11732
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRODISC-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• 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: 48 YR
• Patient Weight: 93