MAUDE Adverse Event Report: SYNTHES MONUMENT CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE; METHYL METHACRYLATE FOR CRANIPLASTY

Catalog Number 615.10.01S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Numbness (2415); No Code Available (3191)

Event Date 09/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is not expected to be returned for manufacturer review/investigation.The patient underwent emergency bring-back surgery on (b)(6) 2017 to remove the product "cranios reinforced fast set putty 10cc-sterile" after experiencing numbness in extremities and compression on spinal cord postoperatively.Based on the (cqcchart) decision, off-label used in the procedure as the device malfunction causing serious injury leading to revision surgery.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient underwent removal of cranios reinforced fast set putty on (b)(6) 2017 due to numbness in her extremities and compression on spinal cord.The patient was originally implanted with the product during a thoracic laminectomy procedure on (b)(6) 2017.Bone cement was needed during the procedure; therefore, a 10cc box of cranios was opened.It was reported that the bone cement worked as intended and did not malfunction.An unknown amount of the product was implanted in the patient.The patient underwent emergency bring-back surgery on (b)(6) 2017 to remove the product after experiencing numbness in extremities and compression on spinal cord postoperatively.To the sales consultant¿s knowledge, all of the bone cement was able to be removed and was not replaced with anything.The surgery was successfully completed with no surgical delay.The patient is now in stable condition and is regaining feeling.There is no information about patient's disease history, but it was reported that the patient was in an otherwise healthy condition.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE
• Type of Device: METHYL METHACRYLATE FOR CRANIPLASTY
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6936841
• MDR Text Key: 89178109
• Report Number: 1719045-2017-11043
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 615.10.01S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR