MAUDE Adverse Event Report: SYNTHES USA 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.415

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Irritation (1941); Pain (1994); Discomfort (2330); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Additional product codes: hrs and hwc.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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 a patient underwent revision surgery on (b)(6) 2016 due to non-union and a variable angle (va) condylar plate breakage; it was also noted that the patient had pain, irritation and/or discomfort.The original fracture and implant date were unknown.The broken va condylar plate and fifteen (15) intact screws were removed easily and successfully without surgical delay or additional medical intervention.The patient was revised to a new va condylar plate and screws with bone grafting.Patient status is unknown.Concomitant devices: unknown screws (partial part 02.231.2xx, quantity 5); unknown screws (partial part 02.231.0xx, quantity 3); unknown screws (partial part 214.8xx, quantity 7).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• 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: 5846364
• MDR Text Key: 51156535
• Report Number: 2520274-2016-13892
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• 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
• Treatment: 3 UNKNOWN SCREWS (02.231.0XX)
• Patient Outcome(s): Required Intervention
• Patient Weight: 67