UNKNOWN_K2M_PRODUCT
Received May 25, 2021 · Event occurred Apr 26, 2021
Report 3004774118-2021-00151 · MDR key 11880685
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
- Neck Pain
- No Clinical Signs, Symptoms or Conditions
- Neck Pain
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THIS EVENT CAPTURES A REVIEW OF A CAPRI CLINICAL STUDY. NO FURTHER DEVICE INFORMATION IS AVAILABLE. PATIENT NINE EXPERIENCED NONUNION AND PSEUDOARTHROSIS AT C4 AND C7 APPROXIMATELY 9 MONTHS POST-OPERATIVELY. SURGICAL INTERVENTION OCCURRED WHERE YUKON SUPPLEMENTAL FIXATION WAS ADDED.
Additional Manufacturer Narrative
VISUAL, DIMENSIONAL, MATERIAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. DEVICE AND COMPLAINT HISTORY RECORDS REVIEW COULD NOT BE PERFORMED AS A VALID LOT CODE WAS NOT PROVIDED AND COULD NOT BE OBTAINED. PER THE CLINICAL STUDY, 8.5 MONTHS AFTER SURGERY NONUNION AND PSEUDARTHROSIS AT OCCURRED AT C4 AND C7. THE BRAND OF THE IMPLANT WAS REPORTED AS YUKON, CATALOG AND LOT NUMBERS OF THE DEVICES WERE NOT PROVIDED. SURGICAL INTERVENTION OCCURRED ON (B)(6) 2020. IT IS UNKNOWN IF THE NONUNION IS STRYKER DEVICE RELATED. NON UNION IS ADDRESSED IN THE YUKON RISK FILE AND IN THE YUKON SURGICAL TECHNIQUE. PER THE STG: "BIOLOGICAL FACTOR SUCH AS SMOKING, USE OF NONSTEROIDAL ANTI-INFLAMMATORY AGENTS, THE USE OF ANTICOAGULANTS, ETC. ALL HAVE A NEGATIVE AFFECT ON BONY UNION. POTENTIAL ADVERSE EVENTS INCLUDE, BUT ARE NOT LIMITED TO PSEUDARTHROSIS, LOOSENING, BENDING, CRACKING OR FRACTURE OF COMPONENTS, OR LOSS OF FIXATION IN THE BONE WITH POSSIBLE NEUROLOGIC DAMAGE, USUALLY ATTRIBUTABLE TO PSEUDARTHROSIS, INSUFFICIENT BONE STOCK, EXCESSIVE ACTIVITY OR LIFTING, OR ONE OR MORE OF THE FACTORS LISTED IN CONTRAINDICATIONS OR WARNINGS AND PRECAUTIONS". THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY FROM THE INFORMATION PROVIDED.
Additional Manufacturer Narrative
STATUS AND LOCATION OF THE DEVICE IS UNKNOWN.
Description of Event or Problem
THIS EVENT CAPTURES A REVIEW OF A CAPRI CLINICAL STUDY. NO FURTHER DEVICE INFORMATION IS AVAILABLE. PATIENT NINE EXPERIENCED NONUNION AND PSEUDOARTHROSIS AT C4 AND C7 APPROXIMATELY 9 MONTHS POST-OPERATIVELY. SURGICAL INTERVENTION OCCURRED WHERE YUKON SUPPLEMENTAL FIXATION WAS ADDED.