MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN RECON PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Break (1069)

Patient Problems Bacterial Infection (1735); Fistula (1862); Failure of Implant (1924)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Linked to (b)(4): in (b)(6) 2017, a fistula appeared on the scar justifying a bacteriological sample which confirmed the presence of staphylococcus colonies justifying his hospitalization in the infectious disease department of the timone in marseille where she benefited from a cleaning and then antibiotic infusions.The treatment being poorly tolerated, she was the subject of a new hospitalization in (b)(6) 2017 where patient was offered a new oral treatment.On this occasion, it appeared from the imagery that the material had broken again.This intervention was followed by an early bankruptcy of the mechanical assembly, noted two and a half months later, on (b)(6) 2017, with dismantling of the equipment.From the beginning of (b)(6) 2017, skin fistulization occurred.Superficial swabs taken on (b)(6) 2017, isolated rare colonies of staphylococcus aureus.Surgical revision was performed on (b)(6) 2017 at the private hospital residence of the park by dr.B.For washing and deep samples, which found propionibacterium acnes.Antibiotic therapy with vancomycin, followed by targocid and dalacine in view of the antibiogram, was initiated.Patient was then hospitalized at the ap-hm from (b)(6) 2017 for adaptation of the antibiotic therapy.She returned home on (b)(6) 2017 under cover of an upper limb orthosis.She was hospitalized again, due to drug reactions to antibiotics, for follow-up and adaptation of antibiotic therapy, from (b)(6) 2017, from (b)(6) 2017.This is 3 out of 4 events.

Manufacturer Narrative

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

• Brand Name: UNKNOWN RECON PLATE
• Type of Device: IMPLANT
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12916653
• MDR Text Key: 286357524
• Report Number: 0008031020-2021-00481
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• 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: 11/05/2021
• 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; Hospitalization
• Patient Sex: Female