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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8197670
• Report Number: 8030965-2018-59255
• Device Sequence Number: 10829111
• Product Code: HRS
• UDI-Device Identifier: 10886982170286
• UDI-Public: (01)10886982170286
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K031573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 245.876
• Device Catalogue Number: 245.876
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 110