MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 16MM; CRANIAL IMPLANT

Model Number FF491T

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Post operative (approximately 4 months) loosening of craniofix clip.Originally placed on (b)(6) 2015; surgeon estimates that the bone regressed and is the probable reason for the loosening of the craniofix and cranioplasty implant.Involved component: ci-acrylic-m / custom cranial acrylic implant medium.

Manufacturer Narrative

Manufacturing site evaluation: product was not returned for evaluation.Lot number was not provided; review of manufacturing documents is not possible.The surgeon's estimation that the bone has regressed and this was probably the reason for loosening of craniofix and cranioplasty is plausible because a bone regression (osteonecrosis) can be caused by external factors to the bone.In this case presumably heat, caused by sawing or drilling the skull during the surgery.Corrective / preventive action: not applicable.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 16MM
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5401878
• MDR Text Key: 37238683
• Report Number: 2916714-2016-00042
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K972332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FF491T
• Device Catalogue Number: FF491T
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/20/2016
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 02/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other