MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM RAPID RESORBABLE ADAPTION PLATE 8 HOLES-STERILE; PLATE, BONE

Model Number 851.008.01S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Device report from japan reports an event as follows: it was reported that this was an orif surgery treating zygomatic fracture performed on (b)(6) 2021, with the products in question.The surgery was completed successfully with no surgical delay.From about 3 months after surgery, swelling and disappearance of the cheek on the affected side have been repeated.At first, the surgeon thought the symptom was a foreign body reaction caused by an absorbable plate and decided to continue to follow up until the plate was absorbed.However, the symptom has been persisting 1 year and 5 months after the surgery.The surgeon commented that the clinical symptom was suspected to be angioedema (quincke's edema).No further information is available.This report is for a 1.5mm rapid resorbable adaption plate 8 holes-sterile.This is report 1 of 3 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 851.008.01s.Lot : 7l86421.Release to warehouse date : 13.Apr.2021.Expiration date : na.Supplier: na.Manufacturing site: werk bio oberdorf.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: 1.5MM RAPID RESORBABLE ADAPTION PLATE 8 HOLES-STERILE
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16419029
• MDR Text Key: 310002480
• Report Number: 8030965-2023-02162
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587063607
• UDI-Public: (01)10887587063607
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 851.008.01S
• Device Catalogue Number: 851.008.01S
• Device Lot Number: 7L86421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: RAPIDSORB CORTSCR Ø1.5 L6 2U.; RAPIDSORB CORTSCR Ø1.5 L6 2U.
• Patient Outcome(s): Other