MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ANKYLOS C/X; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number 3101-0408

Device Problems Crack (1135); Positioning Failure (1158); Fracture (1260); Difficult to Insert (1316); Difficult to Remove (1528); Failure to Osseointegrate (1863); Improper or Incorrect Procedure or Method (2017); Loss of Osseointegration (2408); Separation Failure (2547); Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Deformation (2976); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Sinus Perforation (2277); Osteolysis (2377); Inadequate Osseointegration (2646); Nerve Proximity Nos (Not Otherwise Specified) (2647); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

This submission is for the 2q18 asr serious injury events for endosseous dental implants under asr exemption # 1997021.This report summarizes 4646 serious injury events.1122 events were due to loss of osseointegration (device problem code: 2408).1973 events were due to the device failing to osseointegrate (device problem code: 1863).In 1057 events, there was no known device problem reported (device problem code: 2993).384 events involved fracture of the device or a component (device problem code: 1260).25 events involved an improper or incorrect procedure or method (device problem code: 2017).In 18 events, the device was malpositioned (device problem code: 2616).65 events involved a failure to separate of a device or a component (device problem code: 2547).In 1041 events, a positioning failure was reported (device problem code: 1158).In 23 events, it was reported that a device or a device component was cracked (device problem code: 1135).In 76 events, there were issues reported with a screw component (device problem code: 568).In 122 events, there were issues reported with a mount component (device problem code: 887).In 1 event, there was an issue reported with a driver component (device problem code: 795).In 24 events, it was reported that the device was difficult to insert (device problem code: 1316).3 events were due to material deformation (device problem code: 2976).3 events were due to the device material being twisted or bent (device problem code: 2981).In 1 event there was a detachment of the device or a device component (device problem code: 2907).In 1 event it was reported that a device component was difficult to remove (device problem code: 1528).In 4111 events, there was no device problem found during evaluation (evaluation results code: 213).In 382 events, a fracture of a device or device component was found during evaluation (evaluation results code: 3252).In 368 events, a stress problem was identified during evaluation (evaluation results code: 3243).In 130 events, an operational problem was identified (evaluation results code: 114).In 40 events, a friction problem was identified (evaluation results code: 3253).In 2 events, a deformation problem was found during evaluation (evaluation results code: 3211).In 51 events, there are no findings available because the device was not returned for evaluation (evaluation results code: 3221).

Event Description

This report summarizes 4646 reported events.This submission is for the 2q18 asr serious injury events for endosseous dental implants.This report summarizes 4646 serious injury events where patients' experienced endosseous dental implant failure.Of these events, there were: two hundred sixty eight events where erosion occurred.Five events where tissue damage occurred.Six hundred thirty events where inflammation occurred.Six hundred seventy eight events where infection occurred.Four hundred twelve events where patients' experienced osteolysis.One event where a patient experienced sinus perforation.Thirty eight events where patients' experienced pain.One event where a patient experienced swelling.Five events where the nerve proximity was not otherwise specified.One event where wound dehiscence occurred.One event where there was inadequate osteointegration.One event where a patient experienced a fistula.Two events where device fragments remain in patients.

• Brand Name: ANKYLOS C/X
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; steinzeugstrasse 50; mannheim, 68229 ; GM 68229
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; steinzeugstrasse 50; mannheim, 68229 ; GM 68229
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7735424
• MDR Text Key: 115647394
• Report Number: 9681851-2018-00014
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Number of Events Reported: 4646
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3101-0408
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1