MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUFIT PLUG - UNKNOWN SIZE; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/04/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient who had a trufit plug implanted has developed a lesion and that the trufit plug is alleged to have contributed to that medical condition.

Manufacturer Narrative

Device investigation narrative - examination was not possible, as the device has not been returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event.There is no indication of implant failure based on the limited details provided.The products are not available for evaluation.The cause of the chronic pain cannot be determined.We are currently unable to conduct a complete medical assessment based on the limited information provided.Should clinical relevant information become available, a reassessment will be performed based on the information provided.(b)(4).

• Brand Name: TRUFIT PLUG - UNKNOWN SIZE
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5819083
• MDR Text Key: 50327698
• Report Number: 1219602-2016-00431
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1