MAUDE Adverse Event Report: AESCULAP AG & CO. KG 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM; CRANIAL IMPLANTS

Model Number FF016

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2015

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint: thread was cut off.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2015.Mfr.Site evaluaiton: evaluation is ongoing.

• Brand Name: 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM
• Type of Device: CRANIAL IMPLANTS
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen DE 78532
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4713823
• MDR Text Key: 16850270
• Report Number: 2916714-2015-00331
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• PMA/PMN Number: K040080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF016
• Device Catalogue Number: FF016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• 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