MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNKNOWN_FRO_PRODUCT; IMPLANT

Catalog Number UNK_FRO

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/21/2018

Event Type  Injury  

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported by a company representative that during a procedure 2 tooth roots were damaged due to the use of hybrid mmf screws.One (1) tooth will be lost due toroot damage.

Manufacturer Narrative

Although the screws were not returned for investigation, the reported events could be confirmed based on the provided images.Additional information was provided for the case.After evaluation of the correspondence between the sales representative and the surgeon, it was observed that due to the root fractures, the patient will lose two teeth.But a follow-up call with the sales representative has provided the information that the patient will only lose a tooth instead.In the instructions for use, it is stated that the surgeon should verify that all plate holes are directed away from or placed in-between the tooth roots.This could be achieved with the hmmf bender (62-00600) which is intended to be used to redirect plate holes away from or placed in-between the tooth roots.In the clinical evaluation paper for stryker universal smartlock hybrid mmf system authored by dr.(b)(6), md, it is stated that: ¿(¿) the bender is used for in-plane bending of the attachment loops as needed in order to avoid damage to tooth roots while inserting the screws.(¿)¿ further, the sales representative has also provided op reports, post operative images and a description of the used screws during procedure (2.0 6mm self drilling locking screws from the hmmf tray).Fig.1 confirms the tooth loss due to the root fracture whereas fig.2 demonstrates a root fracture.The provided op reports and images were forwarded to stryker¿s medical expert cmf for evaluation.Stryker¿s medical expert cmf has stated that there was a misplacement of screws.Therefore the root cause of the tooth root fractures can be attributed to the screws being misplaced.During the investigation, there are no indications for any systematic design, material or manufacturing related issue.Therefore no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.

Event Description

It was reported by a company representative that during a procedure 2 tooth roots were damaged due to the use of hybrid mmf screws.1 tooth will be lost due to root damage.

• Brand Name: UNKNOWN_FRO_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7276992
• MDR Text Key: 100304102
• Report Number: 0008010177-2018-00015
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• PMA/PMN Number: K050535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_FRO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 01/21/2018
• Supplement Dates FDA Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1