MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CRANIOPLASTIC; METHYL METHACRYLATE FOR CRANIOPLASTY

Catalog Number 43-1280

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) upon completion of the investigation a follow up report will be filed.

Event Description

As reported by the ous affiliate, cranioplastic failed to solidify.No patient harm was reported, but there was a delay of 40 minutes.

Manufacturer Narrative

Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the additional relevant information becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CRANIOPLASTIC
• Type of Device: METHYL METHACRYLATE FOR CRANIOPLASTY
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7302900
• MDR Text Key: 101160056
• Report Number: 1226348-2018-10193
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• PMA/PMN Number: K071791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 43-1280
• Device Lot Number: 8535448
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention