TSPACE PEEK IMPLANT 26X11X7MM

MDR report key: 5190185 · Received October 30, 2015

Report

Report Number: 3005673311-2015-00166
Event Type: Malfunction
Date Received: October 30, 2015
Date of Event: September 25, 2015
Report Date: April 3, 2017
Manufacturer: AESCULAP IMPLANT SYSTEMS
Product Code: MAX
PMA / PMN Number: SEENARRATIVE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PMA / 510 (K) # K060762 / K071983. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

Additional Manufacturer Narrative · 1

INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: MICROSCOPE "KEYENCE- VHX 600 D". DIGITAL-CAMERA "PANASONIC DMC TZ8. MADE A MICROSCOPIC INVESTIGATION OF THE FRACTURE SURFACE. THERE WAS NO EVIDENCE OF MATERIAL OR PRODUCTION ERRORS LIKE BLOW HOLES OR KNIT LINES. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES WE ASSUME, THAT THE IMPLANT WAS HANDLED / IMPLANTED WITH TOO MUCH FORCE. THE FRACTURE SURFACES EXHIBIT THE TYPICAL SIGNS OF FORCED RUPTURES. THE ROOT CAUSE FOR THE PROBLEM IS THEREFORE MOST PROBABLY USER RELATED. RATIONAL: THERE ARE NO HINTS FOR A PRODUCTION OR MATERIAL ERROR / PROBLEM. THERE ARE CURRENTLY NO FURTHER COMPLAINTS WITH THIS LOT AT HAND. CORRECTIVE ACTION: ACCORDING TO (B)(4) THERE IS NO CAPA NECESSARY

Description of Event or Problem · 1

COUNTRY OF COMPLAINT: (B)(6). DURING THE INTRA-OPERATIVE SURGERY THE IMPLANT HAD BROKEN ON TWO PLACES. REMOVAL OF BROKEN PARTS, HAD TO BE X-RAYED AND HAD TO BE SET THE MARKER FOR THE NEW IMPLANT. THE SECOND IMPLANT HAS BEEN SUCCESSFULLY INTRODUCED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
720965	TSPACE PEEK IMPLANT 26X11X7MM	TSPACE PEEK IMPLANTS	MAX	AESCULAP IMPLANT SYSTEMS	FJ687P	52123859

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other