MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: MATRIXMANDIBLE; PLATE,FIXATION,BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates: matrixmandible/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent surgery for lower jaw with the matrixmandible plate in question.Prior to the procedure, on (b)(6) 2020, the surgeon requested the plate and the sales rep arranged it.At an unknown later date, the surgeon requested another different plate (matrix mandible double angle recon plate, p/n: unk) because the incision might be larger, but the sales rep did not arrange the double angle plate by mistake.On (b)(6), the surgeon tried to use the double angle plate, but he found that it was not arranged.The surgeon instead used the matrixmandible plate devising the incision.During the surgery, the matrixmandible plate broke during bending.The surgeon used another matrixmandible plate and the surgery was completed successfully with less than thirty (30) minutes delay.No further information is available.This report is for one (1) unk - plates: matrixmandible.This is report 2 of 2 for (b)(4).

Event Description

Updated event description: it was reported that on (b)(6) 2020, the patient underwent the surgery for lower jaw with the plate (matrix mandible recon plate, p/n: 04.503.740s) in question.On (b)(6) , the surgeon requested the plate (matrix mandible recon plate, p/n: 04.503.740s), and the sales rep arranged it.At a later date, the surgeon requested another plate (matrix mandible double angle recon plate, p/n: unk) because the incision might be larger, but the sales rep didn¿t arrange the double angle plate by mistake.On (b)(6) the surgeon tried to use the double angle plate, but he found that the double angle plate was not arranged.The surgeon had no choice but to use the plate (matrix mandible recon plate, p/n: 04.503.740s) devising the incision.During the surgery, the plate broke because the double angle plate was appropriate originally and the surgeon used the plate forcibly.The surgeon used another plate (matrix mandible recon plate, p/n: 04.503.740s) and the surgery was completed successfully with less than 30 minutes delay.After the surgery, on (b)(6) the sales rep found that the lot number imprinted at the broken plate is different from the lot number of the plate package.No further information is available.This complaint involves two (2) devices.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: UNK - PLATES: MATRIXMANDIBLE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10580569
• MDR Text Key: 208350543
• Report Number: 8030965-2020-07402
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/21/2020
• Patient Sequence Number: 1
• Treatment: MATRIXMAND RECO-PL ANGL R 7+23HO T2.5 TI; MATRIXMAND RECO-PL ANGL R 7+23HO T2.5 TI
• Patient Outcome(s): Required Intervention