MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SILICONE MCP/PIP; IMPLANT

Catalog Number UNK_SEL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned as device remains implanted.If additional information becomes available it will be provided on a supplemental report.

Event Description

Patient reported he has been experiencing dislocations since his left middle finger surgery.He has had 2 nail surgical procedures to fix the dislocations.He doesn't feel is the implant and would like for us to review his x-rays and let him know if it is procedure related.

• Brand Name: UNKNOWN SILICONE MCP/PIP
• 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: 6681937
• MDR Text Key: 78906488
• Report Number: 0008031020-2017-00383
• Device Sequence Number: 1
• Product Code: LXH
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 06/30/2017
• 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