MAUDE Adverse Event Report: ALTATEC GMBH CAMLOG IMPLANT; CAMLOG SCREW LINE IMPLANT

Model Number K1054.5009

Device Problem Malposition of Device (2616)

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

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

The doctor stated he was aware to take a higher risk during implantation in the sinus.Manufacturer decided to issue additional information in the ifu to clearly state that during a open sinus lift procedure when attempting to pull back the implant the insertion post can be removed unintentionally from the implant.Doctor also stated that the patient is fine.

Event Description

During a dental implant insertion with a pre-mounted plugged insertion post on the implant the doctor tried to implant into the sinus.As the sinus is usually soft bone area the doctor pushed the implant too far into the sinus.Based on the plugged connection between the insertion post and the implant it was not possible to pull back the implant.As the doctor tried to re-attach the plugged insertion post he was even pushing the implant into the sinus maxillaris and he needed to use a suction apparatus to retrieve the implant again.

• Brand Name: CAMLOG IMPLANT
• Type of Device: CAMLOG SCREW LINE IMPLANT
• Manufacturer (Section D): ALTATEC GMBH; maybachstr. 5; wimsheim, bw 71299 ; GM 71299
• Manufacturer (Section G): ALTATEC GMBH; maybacgstr. 5; wimsheim, bw 71299 ; GM 71299
• Manufacturer Contact: raphael brausch ; maybachstr. 5; wimsheim, bw 71299 ; GM 71299 ; 99445311
• MDR Report Key: 7284893
• MDR Text Key: 100519465
• Report Number: 9613866-2017-00001
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K051636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: K1054.5009
• Device Lot Number: 0000076644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• 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