MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS PLASMACUP FIXATION SCREW 6.5X20MM; IMPLANTS PLASMACUP

Model Number NA770T

Device Problem Noise, Audible (3273)

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

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that the patient reported hearing squeaking noise.Additional information will be provided.Components in use listed as concomitant devices are: na770t / plasmacup fixation screw 6.5x20 mm (2).Na774t / plasmacup fixation screw 6.5x24 mm.Nh102 / sc/msc ceramic insert 32 mm 48/5.Nh148t / plasmacup msc size 48 mm.Nj108 / bilox prosthesis head 8/10 32 mm l.Nj211t / biocontact d plasmapore 8/10 size 11 mm.

Manufacturer Narrative

Additional information: indicates the device is not marketed in us.Correction of item# (b)(4).According to the provided information, it came to a revision surgery due to a squeaking noise.During the revision surgery, a fracture of the insert was detected.The ceramic insert is fractured.The device history records of the involved components mentioned above has been checked and found to be according to the specification, valid at the time of production.The density of the insert was analyzed and found to be complying with the delivery specification for the components.The microstructure as obtained from the quality documents of both parts accomplishes the requirements as specified at the time of production, too.There are no indications of any pre-existing material defects.There is no indication for a material defect or manufacturing error, there fore we assume most likely a patient (e.G.Overload) or a using related (e.G.Implantation situation) error.A capa is not necessary.

• Brand Name: PLASMACUP FIXATION SCREW 6.5X20MM
• Type of Device: IMPLANTS PLASMACUP
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 6802357
• MDR Text Key: 82990731
• Report Number: 9610612-2017-00433
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042344
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• Device Expiration Date: 05/30/2013
• Device Model Number: NA770T
• Device Catalogue Number: NA770T
• Device Lot Number: 51501131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/15/2017
• Device Age: 9 YR
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2008
• 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): Other; Required Intervention
• Patient Age: 67 YR