MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM LOW PROFILE CURVED RECON PLATE 108MM RADIUS 6 HOLES; PLATE, FIXATION, BONE

Model Number 245.876

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional product code: ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported on (b)(6) 2018, the patient underwent revision due to the broken plate.The patient underwent removal of the plaque , which was fractured on (b)(6) 2018.Initially the patient had an implant on (b)(6) 2017 with 3.5 mm low profile curve reconstruction plate and six (6) cortical screws.It was unknown if all the implanted devices were successfully removed.It was unknown if there was surgical delay.Patient and procedure outcome were unknown.Concomitant device: 3.5 cortical screws (part unknown, lot unknown, quantity 6).This report is for one (1) 3.5mm low profile curved reconstruction plate.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM LOW PROFILE CURVED RECON PLATE 108MM RADIUS 6 HOLES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8197670
• MDR Text Key: 131439537
• Report Number: 8030965-2018-59255
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982170286
• UDI-Public: (01)10886982170286
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K031573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 245.876
• Device Catalogue Number: 245.876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• 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: 110