MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 6H/LEFT 119MM; PLATE, FIXATION, BONE

Model Number	239.957
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient information is not available for reporting.Device is not implanted/explanted.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.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2018, a 3.5mm locking compression plate (lcp) medium proximal tibial left 6 holes was not included in the company's voucher.A 4.5mm lcp proximal tibia plate 6 holes was chosen to proceed with the surgery following the information on the plate.The surgeon was also very annoyed that the surgery was delayed due to the delay in delivery of the material.It was a big surgery, extremely difficult but it turned out all right.Patient outcome is unknown.This report is for one (1) 3.5mm lcp® medial proximal tibia plate 6h/left 119mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5MM LCP® MEDIAL PROXIMAL TIBIA PLATE 6H/LEFT 119MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7857259
• Report Number: 8030965-2018-56189
• Device Sequence Number: 16505205
• Product Code: HRS
• UDI-Device Identifier: 10886982163530
• UDI-Public: (01)10886982163530
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 239.957
• Device Catalogue Number: 239.957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2018
• Initial Report FDA Received Date: 09/07/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention