MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: SYNPOR; PLATE,FIXATION,BONE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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.D1, d2, d3, d4, g5 ¿ 510k: this report is for an unk - plates: synpor/unknown lot.Part and lot numbers are unknown; udi number is unknown.H3, h4, h6: 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 Description

On (b)(6) 2023 the patient was admitted to (b)(6) for repair of a left orbital floor fracture.The operative note states "a resorbable plate made by synthes called synpor smooth orbital plate was used." on (b)(6) 2024 the patient was re-admitted to (b)(6) for infection.The medical records reflect that the incorrect plate was provided during the initial procedure and that her symptoms were a reaction to a plate.Specifically, the medical record states that the plate was supposed to be a resorbable plate and that the rep and company were notified of the error.(b)(6) is requesting reimbursement of the charges incurred in the medical treatment of the patient.This report is for one (1) unk - plates: synpor.This is report 1 of 2 for complaint (b)(4).

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.D10: date of concomitant therapy is (b)(6) 2023.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: SYNPOR
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19054229
• MDR Text Key: 339553228
• Report Number: 8030965-2024-04606
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2024
• 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
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Sex: Female