MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH CRANIAL PANEL 152 MM X 152 MM; PLATE, BONE

Catalog Number 090

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 05/28/2014

Event Type  Injury  

Event Description

It was reported to medtronic neurosurgery that after the ti mesh plate was implanted into the patient it was observed that the edge of the plate was raised.A revision surgery was performed to fix the issue.The facility reported that they do not believe that the product or its shaping contributed to the bent plate edge.It was also reported that the patient was in good condition after the revision surgery.

Manufacturer Narrative

The product was not returned.Therefore an evaluation of the device was not possible.A review of the manufacturing records was not possible as a lot number was not provided.(b)(4).

Manufacturer Narrative

The edge of the returned shaped plate was observed to have a slight upward bend.However, it is unknown if this bend was part of the original shaping mold as a lot number was not provided.Additionally, a review of the manufacturing records was not possible as lot number was not provided.The instructions for use that accompanies the device states that the disassembly, bending, and/or breakage of timesh components is a possible complication associated with the device.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TIMESH CRANIAL PANEL 152 MM X 152 MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: jeffrey henderson ; 125 cremona drive; goleta, CA 93117 ; 8055718445
• MDR Report Key: 3894494
• MDR Text Key: 15365017
• Report Number: 2021898-2014-00214
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 00054 YR