MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI LCP PROX LATERAL TIBIA PL 7 HOLES/180MM/RIGHT-STERILE; PLATE,FIXATION,BONE

Catalog Number 422.222S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event year is reported as 2020; however exact date of event is unknown.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 product was received; 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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported on an unknown date that during an unknown surgery, it was discovered the proper plate is not in back order.The procedure was successful with alternative plate without delay reported.There was no patient consequence.Concomitant device reported: unknown set (part # unknown, lot # unknown, quantity unknown), unknown screws (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) ti lcp prox lateral tibia pl 7 holes/180mm/right-sterile this is report 1 of 1 for (b)(4).

• Brand Name: TI LCP PROX LATERAL TIBIA PL 7 HOLES/180MM/RIGHT-STERILE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10635358
• MDR Text Key: 210016508
• Report Number: 8030965-2020-07736
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819289505
• UDI-Public: (01)07611819289505
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K052390
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 422.222S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - KITS/SETS; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention