MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNKNOWN_FRO_PRODUCT; IMPLANT

Catalog Number UNK_FRO

Device Problems Break (1069); Fracture (1260)

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

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported by a nurse that a maxilla facial plate broke.There is no other information available at this time regarding the event.

Event Description

It was reported by a nurse that a maxilla facial plate broke.There is no other information available at this time regarding the event.

Manufacturer Narrative

The reported device was not returned for evaluation, thus the reported event could not be confirmed.With only the given information that a maxilla plate was broken, this investigation was conducted with minimal information.The customer stated that he gave the broken implant to the responsible sales rep, however the sales rep has left stryker and the location of the device is unknown.Additional data has been requested several times such as the catalog number, initial implantation date, x-rays during initial implantation and during the time the plate was discovered to be broken, as well as, whether bone healing has been achieved despite the broken plate.However, no further information has been provided.Some of the possible root causes according to the related risk management file are: based on statistical evaluation there is no indication for an incorrectly working product or any systematic design, material, or manufacturing related issue.Therefore, no further corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.Should the device be returned or further information becomes available, the investigation will be re-evaluated.

• Brand Name: UNKNOWN_FRO_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8977042
• MDR Text Key: 206986255
• Report Number: 0008010177-2019-00059
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_FRO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1