MAUDE Adverse Event Report: OSTEOMED, LLC OSTEOMED; MFX ANGULATED LOCKING BSSO PLATE 6 HOLE

Model Number	214-2011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Malfunction
Event or Problem Description
On 03aug2020 the sales manager reported a plate fracture explant in (b)(6) with (b)(4).On 05aug2020 the quality analyst at (b)(4) (osteomed distributor) notifies: "patient (b)(6), victim of trauma to the face by a large animal, underwent a surgical procedure on (b)(6) 2021, where temporary stabilization of the mandibular fracture and sutures of the wounds on the face were performed.On (b)(6) 2021, the patient underwent a surgical procedure to treat a complex mandibular fracture on the right side and middle third of the face.At the time, 01 (one) straight plate bsso 04 holes, 01 (one) straight plate bsso 06 holes and 01 (one) trapezoidal plate 05 holes of the 2.0 locked angled system of the osteomed brand were used for fixation of the mandibular fracture of tlhe middle 1/3 of the face.It turns out that, after routine examinations, an image compatible with a 06 hole plate fracture was found in the basilar region of the mandible body.New surgical intervention was performed today (b)(6) 2021, where the two straight angled bsso boards blocked "fron" the 2.0 system were removed and replaced by 01 (one) board 2.4 angled blocked with 6 holes.".
Additional Manufacturer Narrative
The investigation is on going and a supplemental report will be submitted on completion of investigation.
Additional Manufacturer Narrative
The device was not returned for evaluation despite follow up attempts; however, photos were provided that showed the fractured plate.A two year review of capa, ncr, and complaints revealed no capas, ncrs, or complaints of broken bsso plates for this device system.Labeling was reviewed and indicated the instructions for use provides various warnings related to fractured/broken plates.Additionally, risk documentation was reviewed and adequately addresses this failure mode.The device history record was reviewed to ensure each manufacturing and inspection operation was performed.The review revealed no anomalies.

• Brand Name: OSTEOMED
• Common Device Name: MFX ANGULATED LOCKING BSSO PLATE 6 HOLE
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho road; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: flor rivera ; 3885 arapaho rd.; addison, TX 75001 ; 9726774600
• MDR Report Key: 12819568
• Report Number: 2027754-2021-00020
• Device Sequence Number: 17340198
• Product Code: JEY
• UDI-Device Identifier: 00845694026512
• UDI-Public: (01)00845694026512(10)1150950301(11)200922
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K080694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 214-2011
• Device Catalogue Number: 214-2011
• Device Lot Number: 1150950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male