MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AXSOS SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Tissue Damage (2104)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Hospital retained device.

Event Description

It was reported that the patient's left humerus was revised due to the screws pulling out of the patient's bone and the plate cutting out of the bone.Surgeon reported patient's very poor bone quality as a contributing factor.An axsos 10-hole titanium compression plate and 8 screws were revised to an axsos stainless steel proximal humeral plate and screws.Rep reported that no further information is available.

• Brand Name: UNKNOWN AXSOS SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9339002
• MDR Text Key: 184933878
• Report Number: 0008031020-2019-01855
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 64 YR
• Patient Weight: 59