MAUDE Adverse Event Report: AESCULAP AG CRANIOFIX 2 TITANIUM CLAMP 11MM; CRANIAL CLOSURE

Model Number FF490T

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: according to the available information, there were no negative consequences for patient.Received the upper disc of an ff490t.At the first sight, there are no damages visible.A visual inspection of the disc, especially the spring segments.The disc is not bent or scratched.Only slight wear marks (caused by the application) are visible.The spring segments are in a proper condition (not bent or damaged).The definitive lot is unknown.The possible lots (52397378 / 52436748), been checked and found to be according to specification valid during the time of production.There are no similar cases at hand since the last three years.The root cause for the problem is most probably usage related.A capa is not necessary.

Event Description

It was reported by the healthcare professional to the company sales representative "when procedure of closing the skull, upper disk was loosened after the procedure.When the procedure was complete, the lower disk and pin remained.Feedback of the surgeon; free bone flap was relatively big, but fixed with 3 clamps.The surgeon decided to leave the clamp without upper disk.Currently no detailed information about surgery delay of 15 minutes or more.Information is requested.Only the upper disk is available for the investigation.There are two possible batch numbers reported from by the hospital.One is 52397378 and the other is 52436748.According to the hospital, it is possible that 52436748 is the one used.Received contaminated upper disk.

• Brand Name: CRANIOFIX 2 TITANIUM CLAMP 11MM
• Type of Device: CRANIAL CLOSURE
• 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: 8020099
• MDR Text Key: 125506438
• Report Number: 9610612-2018-00479
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF490T
• Device Catalogue Number: FF490T
• Device Lot Number: 52376018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/10/2018
• Date Manufacturer Received: 10/03/2018
• 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): Required Intervention