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

Model Number FF491T

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint states: when the customer cut the pin of the product after fixation, disks were loose.

Manufacturer Narrative

Mfg site eval: eval is ongoing.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 16MM
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4284218
• MDR Text Key: 5299250
• Report Number: 2916714-2014-00734
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K972332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF491T
• Device Catalogue Number: FF491T
• Device Lot Number: 52032082
• Date Manufacturer Received: 09/01/2014
• Date Device Manufactured: 04/28/2014
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other