UNKNOWN_K2M_PRODUCT
Received May 25, 2021 · Event occurred Apr 26, 2021
Report 3004774118-2021-00154 · MDR key 11880867
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
Not reported
- Abdominal Pain
- Dysphagia/ Odynophagia
- Pain
- Swelling/ Edema
- Abdominal Pain
- Dysphagia/ Odynophagia
- Pain
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
VISUAL, DIMENSIONAL, MATERIAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. DEVICE AND COMPLAINT HISTORY RECORDS COULD NOT BE REVIEWED AS A VALID LOT NUMBER WAS NOT PROVIDED AND COULD NOT BE OBTAINED. NO DEVICE INFORMATION NOR ADDITIONAL INFORMATION ABOUT THE PROCEDURE WAS PROVIDED. THERE IS NO STRYKER DEVICE FAILURE REPORTED VIA THIS COMPLAINT THEREFORE NO INVESTIGATION CAN BE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND UPDATED.
Description of Event or Problem
THIS EVENT CAPTURES A REVIEW OF A CAPRI CLINICAL STUDY. NO FURTHER DEVICE INFORMATION IS AVAILABLE. PATIENT TWENTY-NINE EXPERIENCED A PROLONGED HOSPITAL VISIT DUE TO ACUTE RESPIRATORY DISTRESS AND ASPIRATION PNEUMONIA; PROBLEMS SWALLOWING, WORSENING COUGH AND DYSPHAGIA POST-OPERATIVELY. THESE ISSUES RESOLVED FOLLOWING SURGICAL INTERVENTION.
Additional Manufacturer Narrative
STATUS AND LOCATION OF THE DEVICE IS UNKNOWN.
Description of Event or Problem
THIS EVENT CAPTURES A REVIEW OF A (B)(6) CLINICAL STUDY. NO FURTHER DEVICE INFORMATION IS AVAILABLE. PATIENT TWENTY-NINE EXPERIENCED A PROLONGED HOSPITAL VISIT DUE TO ACUTE RESPIRATORY DISTRESS AND ASPIRATION PNEUMONIA; PROBLEMS SWALLOWING, WORSENING COUGH AND DYSPHAGIA POST-OPERATIVELY. THESE ISSUES RESOLVED FOLLOWING SURGICAL INTERVENTION.