MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UN3 BURR HOLE COVER, 20MM, W/TAB; IMPLANT

Catalog Number 53-34520S

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.The product was discarded by the facility at their location.

Event Description

It was reported by a company representative that a revision surgery occurred related to a post-surgical site infection after initial implantation with an implant.There was no actual device malfunction reported or evidence of such, and the procedure was completed successfully without a delay.

Manufacturer Narrative

As stated in the reported event, the feedback from the customer was ¿cannot rule out that the dehiscence is a result of a reaction to the plates.A low grade infection was confirmed after surgery, which most possibly have led to the wound dehiscence.On the other hand, the dehiscence could also be a result of increased intracranial pressure leading to internal pressure on the wound with dehiscence as a result.¿ the customer has confirmed that the reported liquor leakage is a csf leak.This could have been the cause of the reported event (wound dehiscence and liquor leakage).The reported issue was forwarded to the medical expert, as well as, the senior specialist clinical affairs.Both assessed the csf leak as not product related.The medical expert stated, ¿the plates have nothing to do with the dehiscence or leakage.I can¿t speculate but if by ¿liquor¿ they mean csf leakage then that could be the cause of both.Any subcutaneous setons could also cause both.¿ the customer stated in another follow-up that the revision surgery was due to the csf leakage.However, the intended use of the implant is not the restoration nor closure of the dura mater.As stated in the instructions for use (ifu 90-02011 rev.12, 2018-oct-26) related to the reported device, the plate ¿is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).¿ it was discovered from the revision surgery that the patient acquired a superficial infection, which was treated with antibiotics effectively.The organism that has caused the infection is normally present on human skin.Further, the devices are delivered sterile.The senior staff engineer in supplier quality stated that no discrepancies were observed from production control or from microbiological monitoring that may cause the reported infection.In the ifu, it is also stated that infection as an adverse event may rather be clinically related than implant related.The reported wound dehiscence could not be confirmed.The devices could be excluded as the root cause for the reported csf leak.In summary, it is most likely that the devices in question did not cause the reported events.Complaint# (b)(4).The device history records (design proposal, manufacturing documents, inspection plan, inspection drawing and release report) for catalog # 53-34520s, lot # 1000316937 indicate that 32 devices were manufactured and finally packed on 2018-aug-22 with no reported discrepancies.Complaint# (b)(4).The device history records (design proposal, manufacturing documents, inspection plan, inspection drawing and release report) for catalog # 53-34520s, lot # 1000317874 indicate that 110 devices were manufactured and finally packed on 2018-sep-05 with no reported discrepancies.Although the exact root cause cannot be determined, the following are possible root causes according to the related risk management file: damaged product (packaging).Too less/incorrect information in ifu.Repeated use in more than one patient.Product not sterile (sterile packaging).Insufficient packaging design.During the investigation, there were no indications for any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaints are added to the complaint trend.

Event Description

It was reported by a company representative that a revision surgery occurred related to a post-surgical site infection after initial implantation with an implant.There was no actual device malfunction reported or evidence of such, and the procedure was completed successfully without a delay.

• Brand Name: UN3 BURR HOLE COVER, 20MM, W/TAB
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 9298811
• MDR Text Key: 165959159
• Report Number: 0008010177-2019-00069
• Device Sequence Number: 1
• Product Code: GXR
• Combination Product (y/n): N
• PMA/PMN Number: K112557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 53-34520S
• Device Lot Number: 1000317874
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1