MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/14HOLE/301MM/RT-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.414S

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional pro-codes: hrs, hwc.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, a revision surgery was performed due to a nonunion and loss of position into varus.Originally, the patient underwent an implantation of variable angle (va) locking compression plate (lcp) condylar plate for gunshot injury to distal femur on late 2018.Thus, all implants were removed where in all unknown proximal screws were intact and was revised with an unknown angle blade plate with supporting medial small fragment plate.Looked like the distal screw plate interface had disconnected on four (4) unknown distal locking screws where in one (1) unknown distal locking screw was broken at the neck.There was no surgical delay.Surgical procedure was successfully completed.Patient status is unknown.Concomitant device reported: va locking screws (part # 02.231.230, lot# unknown, quantity 1); va locking screws (part # 02.231.234, lot# unknown, quantity 1); va locking screws (part # 02.231.275, lot# unknown, quantity 1); va locking screws (part # 02.231.280, lot# unknown, quantity 1); va locking screws (part # 02.231.285, lot# unknown, quantity 1); va locking screws (part # 02.231.290, lot# unknown, quantity 1) and unknown distal locking screws (part# unknown, lot# unknown, quantity 3).This complaint involves three (3) devices.This report is 1 of 3 for (b)(4).

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14HOLE/301MM/RT-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8597483
• MDR Text Key: 144667011
• Report Number: 8030965-2019-63734
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819455924
• UDI-Public: (01)07611819455924
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K110354
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.414S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• 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 Age: 30 YR
• Patient Weight: 135