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

Model Number	80-1478
Medical Device Problem Code	Device Contamination With Biological Material (2908)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Event or Problem 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: (b)(6).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.
Additional 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.This complaint is now deemed closed.
Additional Manufacturer Narrative
Corrected: event date (event date is on (b)(6) 2018 and not on (b)(6) 2017).Additional information: cross reference mdr#: 2023988-2018-00013 (2 mdrs filed, because 2 different part numbers were provided by the user facility).

• Brand Name: DURAFORM DURAL GRAFT IMPLANT 3X3 INCHES
• Common Device Name: DURA SUBSTITUTE
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7438568
• Report Number: 2023988-2018-00012
• Device Sequence Number: 1055780
• Product Code: GXQ
• UDI-Device Identifier: 10886704036739
• UDI-Public: 10886704036739
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 80-1478
• Device Catalogue Number: 801478
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 03/19/2018; 03/19/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 06/11/2018; 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention