MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Break (1069)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

Device is not available yet.If additional information becomes available it will be provided on a supplemental report.Implanted in patient.

Event Description

Patient called stating she had plate implanted on (b)(6) 2017.Patient started experiencing pain, swelling and difficulty walking around (b)(6) 2018.She visited the surgeon, x-rays were done and the surgeon stated that the titanium plate was broken.Patient has not yet scheduled a revision surgery.

• Brand Name: UNKNOWN PLATE
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7891410
• MDR Text Key: 120824063
• Report Number: 0008031020-2018-00612
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2018
• 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: 61 YR
• Patient Weight: 56