LIF-PTP
Received Jul 15, 2021 · Event occurred Jun 15, 2021
Report 2027467-2021-00047 · MDR key 12174351
Device
Generic name
Keyed Bedrail Clamp
Manufacturer
Alphatec Spine, Inc.Model number
300-351Catalog number
300-351
Product problems
- Mechanical Problem
- Device-Device Incompatibility
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: MEDICAL DEVICE PROBLEM: 2306 MEDICAL DEVICE COMPONENT: 757 TYPE OF INVESTIGATION: 3331; 4114 INVESTIGATION FINDINGS: 4245 INVESTIGATION CONCLUSION: 27 H10: THE REPORT INDICATES THE INCORRECT BEDRAIL CLAMP ((B)(4). ) WAS RECEIVED IN SET PTPARM26. THIS CAUSED A DELAY IN SURGERY. THERE WAS NO REPORT OF DEVICE MALFUNCTION OR PATIENT INJURY. SET PTPARM26 RETURNED TO ATEC WITH THE CORRECT BEDRAIL CLAMP (PN (B)(4). LN 8679401). (B)(4). DID NOT RETURN WITH THE SET. PHOTOGRAPHS WERE NOT PROVIDED TO CONFIRM THE EVENT. A REVIEW OF COMPLAINT RECORDS INDICATES THIS IS THE ONLY REPORT OF INCORRECT BEDRAIL WHICH CAUSED A DELAY IN SURGERY. THE ROOT CAUSE CANNOT BE DETERMINED BUT MAY BE THE RESULT OF A PROCESSING ERROR.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
DURING THE PTP PORTION OF THE PROCEDURE, THE A-ARM WAS INCAPABLE OF LOADING INTO THE BEDRAIL CLAMP, CAUSING A DELAY IN THE CASE. A LIF CLAMP WAS ABLE TO BE UNITIZED WHICH ALLOWED THE CASE TO PROCEED. NO PATIENT INJURY REPORTED.