MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXRIB UNIVERSAL PLATE 8 HOLES; PLATE, FIXATION, BONE

Model Number	04.501.009
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review / investigation.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 reports an event in (b)(6) as follows: it was reported during a chest reconstruction on (b)(6) 2019 screws would not lock into an 8-hole plate.The patient presented to the hospital with a blunt thoracic trauma due to high-speed motorcycle accident, which occurred on (b)(6) 2019.He was hospitalized due to high intensity dependent respiratory pain and functional impotence.The patient underwent thoracic tomography that showed multiple right costal fractures, misaligned in the ninth right costal arch.Ct scan suggests right lower lobe pulmonary contusion / atelectasis associated with laminar hemothorax.Multiple procedures including were required to treat the injuries.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity # unknown).This is report 1 of 2 for (b)(4).

• Brand Name: TI MATRIXRIB UNIVERSAL PLATE 8 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9125001
• Report Number: 8030965-2019-68751
• Device Sequence Number: 19464823
• Product Code: HRS
• UDI-Device Identifier: 10887587017082
• UDI-Public: (01)10887587017082
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K161590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2019

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: 04.501.009
• Device Catalogue Number: 04.501.009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 09/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR