MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

Device Problems Break (1069); Unintended Movement (3026)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This report is for an unknown plates: mandible locking/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.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.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient had a scheduled mandible reconstruction with a diagnosis of a wound by firearm which was previously operated in 1998 and 2006.The surgery was performed, the osteosynthesis plates were exposed (unknown commercial housetension plate and lock mandible plate) and loosen osteosynthesis material in the jaw.However, the surgeon decided to postpone the surgical time for mandible reconstruction due to the infection in an old operative site, granulation tissue, submental fistula with seropurulent drainage, fractured osteosynthesis material and pseudoarthrosis in bone healing.In addition, the opened plate was packed in a double bag with the security label and was left inside the container for logistics to do its respective process.It is unknown if when will be the specific time to continue the surgery.This complaint involves an unknown number of devices.This report is for one (1) unk - plates: mandible locking this report is 3 of 3 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8379979
• MDR Text Key: 137511076
• Report Number: 8030965-2019-61610
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2019
• 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: 38 YR