MAUDE Adverse Event Report: SYNTHES USA 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/85MM; PLATE,FIXATION,BONE

Catalog Number 02.231.285

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient initials are: (b)(6).Additional product codes are: hrs, hwc.(b)(4).Device is not expected to be returned for manufacturer review/investigation.This patient developed implant loosening, and malreduction, which resulted in additional surgical intervention.During removal surgery, the surgeon discovered infection at the implant site, and was able to remove all hardware intact.Subject device has not been received.Without a lot number, the device history record review and 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

It was reported that a patient was implanted with an unknown implant at an unknown point in time.The patient returned to the clinic with a loosening of the implant and a malreduction.Patient and surgery outcome is unknown.Patient returned to surgery on (b)(6) 2016.Surgeon removed hardware and patient had an infection at site.Surgeon stated that the patient had walked on the implants.All hardware was removed without fragments.There was no surgical delay and the procedure was completed successfully.This report is 16 of 19 for (b)(4).

• Brand Name: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/85MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5720216
• MDR Text Key: 47226395
• Report Number: 2520274-2016-13135
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• 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 Weight: 77