FDA Adverse Event Injury Summary report: N

COMPRESSURE FRACTURE REPAIR IMPLANT

MDR report key: 2051292 · Received April 6, 2011

Report

Report Number: 3007511979-2011-00001
Event Type: Injury
Date Received: April 6, 2011
Date of Event: March 14, 2011
Report Date: April 5, 2011
Manufacturer: USI ORTHOPAEDICS LLC DBA U.S. ORTHOPAEDICS
Product Code: HTN
PMA / PMN Number: K081813
Removal / Correction Number: 0001
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADD'L CATALOG #: 1200-122, 1200-125, 1200-002, 1200-004, 1200-005, 1200-131. ADD'L LOT#: 13525-003, 13525-004, 11726-008, 14062-001, NOT RECORDED, 12597-3. (B)(4). DEVICE NOT RETURNED TO (B)(4), UNABLE TO TEST. CAUSE FOR INFECTION NOT ABLE TO RECREATE PRE/INTRA/POST OPERATIVE ENVIRONMENT CONDITIONS EX-PERCEIVED BY THIS PATIENT-THUS, IDENTIFY ROOT CAUSE OF INFECTION.

Description of Event or Problem · 1

PATIENT SUSTAINED PATELLA FRACTURE, PHYSICIAN IN (B)(6) REPAIRED USING OUR COMPRESSOR FRACTURE REPAIR IMPLANT SYSTEM, ON (B)(6) 2011. ON (B)(6) 2011, PHYSICIAN IN (B)(6), NOTIFIED MY OFFICE ABOUT PATIENT HAVING AN INFECTION AT THE SURGICAL SITE (PATELLA) REQUIRING HARDWARE REMOVAL, IN ORDER TO RESOLVE THE INFECTION. OPERATIVE REMOVAL AND CLEANSING OF SITE CONDUCTED ON (B)(6) 2011.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COMPRESSURE FRACTURE REPAIR IMPLANT	HTN/HWC	HTN	USI ORTHOPAEDICS LLC DBA U.S. ORTHOPAEDICS	NA	13525-002

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Required Intervention	FIBERWARE USED IN CONJUCTION WITH COMPRESURE\| FOR PATELLA FIXATION\| SUTURE