MAUDE Adverse Event Report: OSTEOMED OSTEOMED; SHORT, LEFT, RECONSTRUCTION PLATES

Model Number	214-0102
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The short, left, reconstruction plate, p/n 214-0102, was implanted on (b)(6) 2019.Slightly more than two months post-op, on (b)(6) 2019, the plate was found to be broken.A copy of the x-ray was provided.As of (b)(6) 2020, the plate had not been explanted.Several surgical related questions were sent for the surgeon to answer, but no response has been received.The possible causes that could have contributed to the post-op plate breakage include: a non-compliant patient, a secondary trauma to the mandible, possible screw failure (non-osteomed screws), inadequate plate design specifications, improper plate size selection, no or slow osteogenesis, excessive bending of the plate pre-implantation, insufficient bone, poor bone quality, and that the plate experienced/endured excessive abnormal functional stresses.Review of the dhr did not identify any non-conformances associated with lot release.A two-year review did not identify any capas or ncrs related to this implant.This is the only complaint for this issue, "broken plate - post-op", discovered in a two-year review of the complaint database for mandible reconstruction plates.This plate is a part of the m3-m4-cfx system.The risk document is fmea-0603, revision w.The risk of a non-union of bone, a misalignment of bone, or a collapse of the fracture, due to a plate breaking in-vivo is covered in the fmea.The risk has a severity rating of 3.Per sop-eng-006, a rating of 3 indicates a "serious" severity level (results in injury or impairment requiring professional medical intervention).The probability rating is a 1, which per sop-eng-006 is a "low" (unlikely to happen, rare, remote).The final predicted risk level is "low".The m3/m4/cfx instructions for use (ifu) is p/n 030-1552, revision ad.The ifu lists contraindications such as using this system in a patient who might ignore the limitations of rigid fixation plate and screw implants and/or in patients where there is insufficient bone or poor bone quality.The ifu also warns about using an undersized plate or screw in areas of high functional stresses (such as the mandible) which could lead to plate failure.It also states that multiple bending may weaken the plate and could result in plate failure.The ifu states that the osteomed fixation system plates are not intended to endure excessive abnormal functional stresses.This plate is intended for temporary fixation only until osteogenesis occurs.Finally, the ifu states, "dedicated osteomed plates, screws, and instrumentation are required for each surgery." this issue will be monitored through routine trending.
Event or Problem Description
On (b)(6) 2020 osteomed was notified of a patient diagnosed odontogenic keratocytes angulus mandibula sinistra, operated with segmental resection and used osteomed plate and 7 pcs of other brand screw (osteonic - made in (b)(6).Two (2) month after surgery (b)(6) 2019), osteomed plate was found to be broken.

• Brand Name: OSTEOMED
• Common Device Name: SHORT, LEFT, RECONSTRUCTION PLATES
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison, tx
• MDR Report Key: 9711550
• Report Number: 2027754-2020-00002
• Device Sequence Number: 3270144
• Product Code: HRS
• UDI-Device Identifier: 00845694003742
• UDI-Public: (01)00845694003742
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K911936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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: 214-0102
• Device Catalogue Number: 214-0102
• Device Lot Number: 1038007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR