MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MINI PLATE, STRAIGHT, 4-HOLES, LONG BAR; IMPLANT

Model Number 55-10503

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that it was noticed during a post op scan that the plate was broken.There will be a revision surgery performed to remove the plate.

Manufacturer Narrative

The device was received at the manufacturer for testing.An evaluation was conducted and the investigation results show that the postoperative plate fracture occurred through a fixing hole, so the reported event could be confirmed.No lot number was provided, thus a review of the specific manufacturing batch records and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) cannot be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lot.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.

Event Description

It was reported that it was noticed during a post op scan that the plate was broken.There will be a revision surgery performed to remove the plate.

• Brand Name: MINI PLATE, STRAIGHT, 4-HOLES, LONG BAR
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 14980823
• MDR Text Key: 295683171
• Report Number: 0008010177-2022-00021
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 04546540366214
• UDI-Public: 04546540366214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 55-10503
• Device Catalogue Number: 55-10503
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2022
• 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