MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PSI SD800.433 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number SD800.433

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

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes sales consultant.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.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 (b)(4) reports an event as follows: it was reported that on (b)(6) 2019, a patient underwent an unknown surgery to remove a tumor and a cranioplasty was also performed.During the procedure, the frontal sinuses were opened and few days after the surgery, the patient developed an infection.Thus, implants had to be removed to treat an infection.It was unknown if there was surgical delay.Surgical procedure and patient outcome were unknown.This report is for a patient specific implant.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.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

The procedure was successfully completed with no surgical delay.

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.Updated event description provided for reporting.Reporters information provided.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

(b)(6) 2019: updated event description: it was reported that on (b)(6) 2019, a patient underwent an unknown surgery to remove a tumor and a cranioplasty was also performed.During the procedure, the frontal sinuses were opened and few days after the surgery, the patient developed an infection.Thus, implants had to be removed to treat an infection.It was unknown if there was surgical delay.It was reported that patient developed typical signs of local wound infection,erythema, pain, infectious secretion from wound, radiological signs of infected collection around the implant, elevation of laboratory parameters of inflammation.Surgical procedure was successfully completed.Patient has fully recovered and no neurological deficit.

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.Device history lot part: sd800.433 lot: 2l74938 manufacturing site: mezzovico release to warehouse date: 11.Dec.2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: PSI SD800.433 PEEK IMPLANT
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8374874
• MDR Text Key: 137293337
• Report Number: 8030965-2019-61489
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07611819341333
• UDI-Public: (01)07611819341333
• Combination Product (y/n): N
• PMA/PMN Number: K053199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SD800.433
• Device Lot Number: 2L74938
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention