MAUDE Adverse Event Report: SYNTHES MEZZOVICO 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATE 2H/79MM; PLATE,FIXATION,BONE

Catalog Number	02.120.702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age was reported as (b)(6) years.Date of event is unknown.Device is not expected to be returned for manufacture review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot number 9876055.Manufacturing location: (b)(4).Date of manufacture: march 21, 2016.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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
It is reported patient was implanted with two (2) 3.5 locking compression plate (lcp) proximal tibia plates, nine (9) locking screws, and three (3) cortical screws on (b)(6) 2016 to repair a left tibia plateau fracture.On unknown date, patient presented with infection at the implant site.Patient was returned to surgery on (b)(6) 2017 where surgeon removed all hardware.Patient fracture was sufficiently healed, no additional hardware was implanted.Wound was cleaned, debrided, and antibiotic beads were applied.All explanted hardware was intact.An additional x-ray was taken post-operatively to verify no hardware remained.Surgery was completed successfully with no delay and no harm to patient.This is report 2 of 4 for (b)(4).

• Brand Name: 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATE 2H/79MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 6264061
• Report Number: 1000562954-2017-10004
• Device Sequence Number: 1004334
• Product Code: HRS
• UDI-Device Identifier: 10886982040220
• UDI-Public: (01)10886982040220(10)9876055
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2017

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 Catalogue Number: 02.120.702
• Device Lot Number: 9876055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2017
• Initial Report FDA Received Date: 01/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 79