MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. DURAFORM DURAL GRAFT IMPLANT 3X3 INCHES; DURA SUBSTITUTE

Model Number 80-1474

Device Problems Device Contamination With Biological Material (2908); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

Cross reference medwatch mfr report # 2023988-2018-00012.Physician was not sure what product code # (catalog #) he used during the procedure.As a result, we will be submitting two mdr reports to address the 2 product codes provided.

Event Description

The following was reported on a spreadsheet which natus received from codman on 19march2018: "a patient developed an infection after duraform was used and a revision surgery was performed." event date: dec.Unk.A surgeon revised a surgery after several days of initial surgery due to infection.They found duraform was infected by certain types of bacteria.He said he saw several cases of infection on duraform.Surgeon feels that the device contributed to the problem.Device was discarded and will not be returned for evaluation.

Manufacturer Narrative

Additional information received 11june2018: lot number unknown three attempts were made by codman to try to obtain the product for evaluation.22may2018: product status changed to: sample discarded.There was no surgical delay reported.Natus completed their investigation on 07june2018.Investigation results forwarded by codman on 11june2018 included the following: methods: review of device history records.Review of complaints history.Investigation summary: as reported by the ous affiliate, the patient developed an infection after duraform was used during a surgery.A revision surgery was performed.The lot number is unknown.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.A review of complaint records for the previous 12 months could not be performed as no lot number information was provided.The most recent complaint and smt presentation was reviewed and did not show that this product family exceeded its upper control limit for complaints.Trends will be monitored for this or similar complaints.Investigation methods/evaluation results: complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.Root cause category: undetermined : insufficient information failure code codman : product analysis : device not returned root cause description complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.No further corrective & preventative actions proposed.No corrective action required based on the above evaluation.Trends will be monitored for this or similar complaints.Cross reference mdr # 2023988-2018-00012 (2 mdrs filed, because 2 different part numbers provided by the user facility).This complaint is now deemed closed.

Manufacturer Narrative

Event date corrected to march 15th, 2018.

• Brand Name: DURAFORM DURAL GRAFT IMPLANT 3X3 INCHES
• Type of Device: DURA SUBSTITUTE
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7440301
• MDR Text Key: 105841643
• Report Number: 2023988-2018-00013
• Device Sequence Number: 1
• Product Code: GXQ
• UDI-Device Identifier: 10886704036692
• UDI-Public: 10886704036692
• Combination Product (y/n): N
• PMA/PMN Number: K152481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 80-1474
• Device Catalogue Number: 801474
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention