N
Patient 1
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
MAUDE MDR 9728327
- MDR report key
- 9728327
- Report number
- 9610612-2019-00955
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-10
- Date received
- 2020-02-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS KERSTIN ROTHWEILER
- Address
- PO BOX 40 TUTTLINGEN, 78501 GM
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LOVE-GRUENWALD RONGEURSTR3X10MM180MM | BONE PUNCHES, | AESCULAP AG | HTX | FF805R | FF805R | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-19 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH LOVE-GRUENWALD RONGEUR. ACCORDING TO THE CUSTOMER REPORT: "DURING THE REMOVAL (HERNIATED DISC), THE MIDDLE GRASPING FORCEPS IN THE INTERVERTEBRAL DISC SPACE BREAK OFF. THE BROKEN-OFF PART CANNOT BE RECOVERED IMMEDIATELY. MULTIPLE RINSING OF THE INTERVERTEBRAL SPACE WITH SALINE SOLUTION TO REMOVE REMAINING DISC PARTICLES AND MOBILIZATION OF THE METAL FRAGMENT. X-RAY CONTROL. THE METAL FRAGMENT IS LOCATED IN THE CRANIAL PART OF THE INTERVERTEBRAL DISC. PALPATION OF THE INTERVERTEBRAL DISC SPACE WITH THE NERVE HOOK AND FURTHER GRASPING FORCEPS. THERE WILL BE A SMALL BLEEDING FROM THE DEPTHS IS DETECTED WHICH STOPS SPONTANEOUSLY. THE TISSUE REMOVED NOW ISN'T ALWAYS TYPICAL FOR INTERVERTEBRAL DISCS. FURTHER REMOVAL RESULTS IN THE RUPTURE OF A SECOND (LARGE) GRASPING FORCEPS. THE ANTERIOR FRAGMENT CAN NOW BE RETRIEVED DIRECTLY. ANOTHER RADIOLOGICAL CHECK WITH A METAL SUCTION CUP IN THE INTERVERTEBRAL DISC SPACE. IT IS SHOWN THAT THE SUCTION CUP HAS BEEN ADVANCED TO A FAR RETROPERITONEAL POSITION, WITH A PERFORATION OF THE ANTERIOR LONGITUDINAL LIGAMENT. THE FURTHER SEARCH FOR THE METAL FRAGMENT IS STOPPED. A FINAL CHECK FOR BLOOD DRYNESS IS PERFORMED. AN IMMEDIATELY PERFORMED COMPUTED TOMOGRAPHY (CT) ABDOMEN SHOWS A SMALL RETROPERITONEAL BLEEDING, WITHOUT ARTERIAL COMPONENT. AIR IS SHOWN RETROPERITONEALLY IN FRONT OF THE DISC SPACE L5/S1 LEFT AND RIGHT. THERE IS ALSO SOME INTRAPERITONEAL FREE AIR DETECTABLE, PROBABLY BY PUNCTURE WITH THE SUCTION CUP. POSTOPERATIVELY TRANSFER TO THE INTENSIVE CARE UNIT FOR OBSERVATION. A REVISION SURGERY WAS NECESSARY. PLANNED ENDOSCOPIC RECOVERY OF THE FORCEPS FRAGMENT ON (B)(6) 2020. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2019-00944 ((B)(4) FF807R).