MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE 3.5MM / L14MM; PLATE, FIXATION, BONE

Model Number PLSL3514

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded by hospital.

Event Description

It was reported that the two locking screws did not lock into the plate holes.

• Brand Name: LOCKING SCREW ANCHORAGE 3.5MM / L14MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: kristen canter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12391377
• MDR Text Key: 268908369
• Report Number: 0008031020-2021-00391
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252262343
• UDI-Public: 07613252262343
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K083447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLSL3514
• Device Catalogue Number: PLSL3514
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1