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 Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time, this complaint is considered closed.Device not available.

Event Description

It was reported that the surgeon felt that the curing speed of the resin was faster than usual during the surgery on (b)(6) 2017.The surgeon was familiar with how to use the product, and the product was kept in the refrigerator.Since the product was used for the patient, it was not possible to return the product.There was no adverse consequence to the patient.No further information was provided by hospital.

Manufacturer Narrative

An update to the investigation reveals the following: the subject product was not returned for evaluation (or unused product from same lot).However, supplier response to this complaint is as follows: ¿it was reported that the surgeon felt that the curing speed of the resin was faster than usual during the surgery on (b)(6) 2017.The surgeon was familiar with how to use the product, and the product was kept in the refrigerator.¿ the mixing and use of bone cement can be significantly affected by exposure to high or low temperatures up to 24 hours before use.This can cause wide fluctuations in working and setting time.The optimum temperature for bone cement is 23 degrees celsius as per the ifu.The ifu does not state a requirement for bone cement to be kept in a refrigerator.Also, the cement must be allowed to equilibrate at 23°c for at least 24hrs before use.If this does not happen, then the cement may not work as desired.The ifu states; ¿acrylic resins are heat sensitive.Any increase or decrease in temperature (either ambient, and/or of the resin components), from the recommended temperature of 73°f (23°c) will affect the handling characteristics and setting time of the resin.Note: manual handling and body temperature will reduce the final setting time.¿ the dfmea has been reviewed and it gives reference to improper cement characteristics due to cement sensitivity to environmental temperature during storage and distribution, and references the ifu information mentioned above, on line 49, (occurrence 2, risk 10, bar).This is our response for setting time issues when testing has not confirmed the problem.A review of the device history records did not show any anomalies.If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

• Brand Name: CRANIOPLASTIC
• Type of Device: METHYL METHACRYLATE FOR CRANIOPLASTY
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6725396
• MDR Text Key: 80661139
• Report Number: 1226348-2017-10498
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 43-1280
• Device Lot Number: 8159206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1